{ "FullStudy":{ "Rank":217561, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519791", "OrgStudyIdInfo":{ "OrgStudyId":"RA0055 Period 1" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-001729-25", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"UCB Pharma", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis", "OfficialTitle":"A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis", "Acronym":"C-early" }, "StatusModule":{ "StatusVerifiedDate":"March 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"Yes", "ExpandedAccessNCTId":"NCT03559686", "ExpandedAccessStatusForNCTId":"Available" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"July 8, 2015", "ResultsFirstSubmitQCDate":"August 19, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"September 22, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 4, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 31, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"UCB Pharma SA", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Rheumatoid Arthritis" ] }, "KeywordList":{ "Keyword":[ "Certolizumab Pegol - Cimzia", "Methotrexate", "Rheumatoid Arthritis" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"880", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Certolizumab Pegol + Methotrexate", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Certolizumab Pegol", "Biological: Methotrexate" ] } },{ "ArmGroupLabel":"Placebo + Methotrexate", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Placebo", "Biological: Methotrexate" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"Certolizumab Pegol", "InterventionDescription":"Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 50.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Certolizumab Pegol + Methotrexate" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Cimzia", "CZP" ] } },{ "InterventionType":"Other", "InterventionName":"Placebo", "InterventionDescription":"2 syringes Placebo at Baseline, Week 2 and Week 4, followed by 1 syringe Placebo every 2 Weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo + Methotrexate" ] } },{ "InterventionType":"Biological", "InterventionName":"Methotrexate", "InterventionDescription":"The MTX treatment is to be initiated at a dose of 10 mg per Week (oral tablets at the strength of 2.5 mg/tablet). The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8. Patients who could not tolerate ≥ 15 mg/week MTX by Week 8 were withdrawn while the maximum tolerated dose per patient (optimized dose) was maintained to Week 52.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Certolizumab Pegol + Methotrexate", "Placebo + Methotrexate" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "MTX" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of Subjects in Sustained Remission at Week 52", "PrimaryOutcomeDescription":"Sustained remission is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at both Weeks 40 and 52.\n\nDAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:\n\n0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.", "PrimaryOutcomeTimeFrame":"Week 52" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52", "SecondaryOutcomeDescription":"Sustained LDA is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) ≤ 3.2 at both Weeks 40 and 52.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52", "SecondaryOutcomeDescription":"Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52", "SecondaryOutcomeDescription":"Radiographic non-progression is defined as change in mTSS ≤ 0.5.", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Joint Erosion Score to Week 52", "SecondaryOutcomeDescription":"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.\n\nThe maximum possible erosion score for all 32-hand joints was 160. The maximum possible erosion score for all 12 feet joints was 120. Thus, the maximum possible total erosion score for hands and feet was 280.", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Joint Narrowing Score to Week 52", "SecondaryOutcomeDescription":"Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The maximum possible score for JSN in all 30 hand joints was 120. The maximum possible score for JSN in all 12 feet joints was 48. Thus, the maximum possible total JSN score for Hands and feet was 168.", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52", "SecondaryOutcomeDescription":"The assessments are based on a 20 % or greater improvement from Baseline in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52", "SecondaryOutcomeDescription":"The assessments are based on a 50 % or greater improvement from Baseline in the number of tender joints, a 50 %, or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52", "SecondaryOutcomeDescription":"The assessments are based on a 70 % or greater improvement from Baseline in the number of tender joints, a 70 %, or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52", "SecondaryOutcomeDescription":"The ACR/EULAR 2011 remission criteria is defined as:\n\nTender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1, C-reactive protein (CRP) ≤ 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52", "SecondaryOutcomeDescription":"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects With Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52", "SecondaryOutcomeDescription":"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52", "SecondaryOutcomeDescription":"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:\n\n0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 52", "SecondaryOutcomeDescription":"The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:\n\nTender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52", "SecondaryOutcomeDescription":"Good response is defined as:\n\nDAS28[ESR] ≤ 3.2 and decrease from Baseline by > 1.2;\n\nmoderate response is defined as achievement of one of the following:\n\nDAS28[ESR] ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2\nDAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6\nDAS28[ESR] > 5.1 and decrease from Baseline >1.2.", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52", "SecondaryOutcomeDescription":"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:\n\n0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52", "SecondaryOutcomeDescription":"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.\n\nThe CDAI score ranges from 0 to 76, with a negative value in CDAI change from Baseline indicating an improvement from Baseline.", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52", "SecondaryOutcomeDescription":"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.\n\nThe SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline.", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52", "SecondaryOutcomeDescription":"Normative physical function is defined as HAQ-DI score ≤ 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.\n\nThe total score ranges from 0 to 3 with lower scores meaning lower disability.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52", "SecondaryOutcomeDescription":"The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.\n\nThe total score ranges from 0 (no difficulty) to 3 (unable to do) with lower scores meaning lower disability.\n\nA negative value in HAQ-DI change from Baseline indicates an improvement from Baseline.", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52", "SecondaryOutcomeDescription":"BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue).\n\nA negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline.", "SecondaryOutcomeTimeFrame":"From Baseline (Week 0) to Week 52" },{ "SecondaryOutcomeMeasure":"Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "SecondaryOutcomeDescription":"Number of work days missed in the last month for employed subjects.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "SecondaryOutcomeDescription":"Number of work days with reduced productivity in the last month for employed subjects.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "SecondaryOutcomeDescription":"The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "SecondaryOutcomeDescription":"Number of days with no household work in the last month.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "SecondaryOutcomeDescription":"Number of days with reduced household work productivity in the last month.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "SecondaryOutcomeDescription":"Number of days with hired outside help in the last month.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "SecondaryOutcomeDescription":"Number of days missed of family/social/leisure activities in the last month.", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "SecondaryOutcomeDescription":"The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).", "SecondaryOutcomeTimeFrame":"Week 52" },{ "SecondaryOutcomeMeasure":"Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52", "SecondaryOutcomeDescription":"LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2.", "SecondaryOutcomeTimeFrame":"Week 52" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects must have a time since diagnosis of adult-onset Rheumatoid Arthritis (RA) less than 1 year as defined by the 2010 ACR/EULAR classification criteria from Screening Visit\nPositive Rheumatoid Factor (RF) and/or positive anticyclic Citrullinated Peptide Antibody (anti-CCP)\nActive RA disease\nDMARD-naïve\nSubject is naïve to RA related biologics\n\nExclusion Criteria:\n\nA diagnosis of any other inflammatory Arthritis\nHistory of infected joint prosthesis, or other significant infection and other serious medical condition\nKnown Tuberculosis (TB) disease or high risk of acquiring TB infection", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"UCB Clinical Trial Call Center", "OverallOfficialAffiliation":"+1 877 822 9493 (UCB)", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"209", "LocationCity":"Birmingham", "LocationState":"Alabama", "LocationCountry":"United States" },{ "LocationFacility":"170", "LocationCity":"Huntsville", "LocationState":"Alabama", "LocationCountry":"United States" },{ "LocationFacility":"180", "LocationCity":"Mobile", "LocationState":"Alabama", "LocationCountry":"United States" },{ "LocationFacility":"247", "LocationCity":"Glendale", "LocationState":"Arizona", "LocationCountry":"United States" },{ "LocationFacility":"165", "LocationCity":"Paradise Valley", "LocationState":"Arizona", "LocationCountry":"United States" },{ "LocationFacility":"234", "LocationCity":"Paradise Valley", "LocationState":"Arizona", "LocationCountry":"United States" },{ "LocationFacility":"243", "LocationCity":"Phoenix", "LocationState":"Arizona", 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"LocationCity":"London", "LocationCountry":"United Kingdom" },{ "LocationFacility":"80", "LocationCity":"Sheffield", "LocationCountry":"United Kingdom" },{ "LocationFacility":"119", "LocationCity":"York", "LocationCountry":"United Kingdom" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"27165179", "ReferenceType":"result", "ReferenceCitation":"Emery P, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, Arendt C, Mountian I, Purcaru O, Tatla D, VanLunen B, Weinblatt ME. Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naïve patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study. Ann Rheum Dis. 2017 Jan;76(1):96-104. doi: 10.1136/annrheumdis-2015-209057. Epub 2016 May 10." },{ "ReferencePMID":"28666080", "ReferenceType":"result", "ReferenceCitation":"Weinblatt ME, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, VanLunen B, Ecoffet C, Cioffi C, Emery P. A Phase III Study Evaluating Continuation, Tapering, and Withdrawal of Certolizumab Pegol After One Year of Therapy in Patients With Early Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Oct;69(10):1937-1948. doi: 10.1002/art.40196. Epub 2017 Sep 12." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Product Information", "SeeAlsoLinkURL":"http://www.cimzia.com/pdf/Prescribing_Information.pdf" },{ "SeeAlsoLinkLabel":"FDA Safety Alerts and Recalls", "SeeAlsoLinkURL":"http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"A total of 880 subjects were randomized. Three subjects were randomized in error, were not dosed, and withdrawn shortly afterwards as screen failures. Two of them were included in the Randomized Set 1 (RS1) only and one of these three subjects was conservatively excluded from any output. Therefore, 879 subjects are in RS1.", "FlowRecruitmentDetails":"This study started to enroll subjects in January 2012.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Placebo + Methotrexate", "FlowGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Certolizumab Pegol + Methotrexate", "FlowGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"219" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"660" } ] } },{ "FlowMilestoneType":"Completed Week 52", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"143" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"500" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"67" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"292" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"152" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"368" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"SAE,non-fatal + AE,non-serious non-fatal", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"6" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"19" } ] } },{ "FlowDropWithdrawType":"Other Reason", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"87" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"222" } ] } },{ "FlowDropWithdrawType":"subjects randomized in error", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"16" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"20" } ] } },{ "FlowDropWithdrawType":"SAE, non-fatal", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"6" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"22" } ] } },{ "FlowDropWithdrawType":"AE, serious fatal", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"SAE, fatal + SAE, non-fatal", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"AE, non-serious non-fatal", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"12" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"31" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"15" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"37" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"6" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"14" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Baseline Charactersitics refer to the Randomized Set (RS).", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Placebo + Methotrexate", "BaselineGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Certolizumab Pegol + Methotrexate", "BaselineGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total Title" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"219" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"660" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"879" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"182" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"560" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"742" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"36" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"98" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"134" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"51.3", "BaselineMeasurementSpread":"13.2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"50.5", "BaselineMeasurementSpread":"13.6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"50.7", "BaselineMeasurementSpread":"13.5" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"175" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"499" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"674" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"44" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"161" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"205" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Subjects in Sustained Remission at Week 52", "OutcomeMeasureDescription":"Sustained remission is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at both Weeks 40 and 52.\n\nDAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:\n\n0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"28.9" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):\n\nPrimary: sustained DAS28(ESR) remission at Week 52\nKey secondary: sustained DAS28(ESR) LDA at Week 52\nACR50 response at Week 52 in relation to Baseline\nChange from Baseline in HAQ-DI at Week 52\nChange from Baseline in mTSS at Week 52", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"2.283", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.503", "OutcomeAnalysisCIUpperLimit":"3.468", "OutcomeAnalysisEstimateComment":"The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52", "OutcomeMeasureDescription":"Sustained LDA is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) ≤ 3.2 at both Weeks 40 and 52.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"28.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"43.8" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):\n\nPrimary: sustained DAS28(ESR) remission at Week 52\nKey secondary: sustained DAS28(ESR) LDA at Week 52\nACR50 response at Week 52 in relation to Baseline\nChange from Baseline in HAQ-DI at Week 52\nChange from Baseline in mTSS at Week 52", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"1.957", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.384", "OutcomeAnalysisCIUpperLimit":"2.767", "OutcomeAnalysisEstimateComment":"The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52", "OutcomeMeasureDescription":"Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.", "OutcomeMeasurePopulationDescription":"The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Radiographic Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Radiographic Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"163" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"528" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.8", "OutcomeMeasurementSpread":"4.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.2", "OutcomeMeasurementSpread":"3.2" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):\n\nPrimary: sustained DAS28(ESR) remission at Week 52\nKey secondary: sustained DAS28(ESR) LDA at Week 52\nACR50 response at Week 52 in relation to Baseline\nChange from Baseline in HAQ-DI at Week 52\nChange from Baseline in mTSS at Week 52", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA on ranks", "OutcomeAnalysisParamType":"Hodges-Lehmann point estimate of shift", "OutcomeAnalysisParamValue":"-0.978", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-1.005", "OutcomeAnalysisCIUpperLimit":"-0.500", "OutcomeAnalysisEstimateComment":"ANCOVA model on the ranks with the terms for treatment, region, and time since RA diagnosis at Baseline (≤4 months or >4 months) as factors and rank Baseline value as a covariate.\n\nConfidence Interval is an asymptotic Moses CI." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52", "OutcomeMeasureDescription":"Radiographic non-progression is defined as change in mTSS ≤ 0.5.", "OutcomeMeasurePopulationDescription":"The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Radiographic Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Radiographic Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"163" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"528" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"49.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"70.3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Joint Erosion Score to Week 52", "OutcomeMeasureDescription":"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.\n\nThe maximum possible erosion score for all 32-hand joints was 160. The maximum possible erosion score for all 12 feet joints was 120. Thus, the maximum possible total erosion score for hands and feet was 280.", "OutcomeMeasurePopulationDescription":"The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Radiographic Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Radiographic Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"163" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"528" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.1", "OutcomeMeasurementSpread":"3.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.1", "OutcomeMeasurementSpread":"2.1" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Joint Narrowing Score to Week 52", "OutcomeMeasureDescription":"Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The maximum possible score for JSN in all 30 hand joints was 120. The maximum possible score for JSN in all 12 feet joints was 48. Thus, the maximum possible total JSN score for Hands and feet was 168.", "OutcomeMeasurePopulationDescription":"The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Radiographic Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Radiographic Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"163" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"528" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.7", "OutcomeMeasurementSpread":"2.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.1", "OutcomeMeasurementSpread":"1.7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52", "OutcomeMeasureDescription":"The assessments are based on a 20 % or greater improvement from Baseline in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"61.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"69.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52", "OutcomeMeasureDescription":"The assessments are based on a 50 % or greater improvement from Baseline in the number of tender joints, a 50 %, or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"52.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"61.8" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):\n\nPrimary: sustained DAS28(ESR) remission at Week 52\nKey secondary: sustained DAS28(ESR) LDA at Week 52\nACR50 response at Week 52 in relation to Baseline\nChange from Baseline in HAQ-DI at Week 52\nChange from Baseline in mTSS at Week 52", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"=0.023", "OutcomeAnalysisStatisticalMethod":"Regression, Logistic", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"1.446", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.052", "OutcomeAnalysisCIUpperLimit":"1.989", "OutcomeAnalysisEstimateComment":"The Odds ratio was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52", "OutcomeMeasureDescription":"The assessments are based on a 70 % or greater improvement from Baseline in the number of tender joints, a 70 %, or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"39.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"51.3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52", "OutcomeMeasureDescription":"The ACR/EULAR 2011 remission criteria is defined as:\n\nTender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1, C-reactive protein (CRP) ≤ 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"32.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52", "OutcomeMeasureDescription":"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"26.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"38.9" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects With Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52", "OutcomeMeasureDescription":"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"24.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"38.9" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52", "OutcomeMeasureDescription":"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:\n\n0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"26.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"42.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 52", "OutcomeMeasureDescription":"The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:\n\nTender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"24.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"35.3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52", "OutcomeMeasureDescription":"Good response is defined as:\n\nDAS28[ESR] ≤ 3.2 and decrease from Baseline by > 1.2;\n\nmoderate response is defined as achievement of one of the following:\n\nDAS28[ESR] ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2\nDAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6\nDAS28[ESR] > 5.1 and decrease from Baseline >1.2.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"82.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"89.9" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52", "OutcomeMeasureDescription":"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:\n\n0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing DAS28(ESR) values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"210" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"646" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-3.014", "OutcomeMeasurementSpread":"0.109" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-3.615", "OutcomeMeasurementSpread":"0.069" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52", "OutcomeMeasureDescription":"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.\n\nThe CDAI score ranges from 0 to 76, with a negative value in CDAI change from Baseline indicating an improvement from Baseline.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing CDAI values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"210" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"644" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-29.09", "OutcomeMeasurementSpread":"0.84" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-33.11", "OutcomeMeasurementSpread":"0.52" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52", "OutcomeMeasureDescription":"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.\n\nThe SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing SDAI values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"210" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"644" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-30.24", "OutcomeMeasurementSpread":"0.88" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-34.55", "OutcomeMeasurementSpread":"0.55" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52", "OutcomeMeasureDescription":"Normative physical function is defined as HAQ-DI score ≤ 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.\n\nThe total score ranges from 0 to 3 with lower scores meaning lower disability.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"35.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"48.1" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52", "OutcomeMeasureDescription":"The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.\n\nThe total score ranges from 0 (no difficulty) to 3 (unable to do) with lower scores meaning lower disability.\n\nA negative value in HAQ-DI change from Baseline indicates an improvement from Baseline.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing HAQ-DI values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"210" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"645" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.819", "OutcomeMeasurementSpread":"0.044" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.997", "OutcomeMeasurementSpread":"0.028" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):\n\nPrimary: sustained DAS28(ESR) remission at Week 52\nKey secondary: sustained DAS28(ESR) LDA at Week 52\nACR50 response at Week 52 in relation to Baseline\nChange from Baseline in HAQ-DI at Week 52\nChange from Baseline in mTSS at Week 52", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Difference in Least Squares (LS) Means", "OutcomeAnalysisParamValue":"-0.177", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.273", "OutcomeAnalysisCIUpperLimit":"-0.082", "OutcomeAnalysisDispersionType":"Standard Error of the Mean", "OutcomeAnalysisDispersionValue":"0.049", "OutcomeAnalysisEstimateComment":"The CfB in HAQ-DI at Week 52 was analyzed using an ANCOVA model with terms for treatment, region, and time since Rheumatoid Arthritis (RA) diagnosis at Baseline (≤4 months or >4 months) as factors and Baseline value as a covariate." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52", "OutcomeMeasureDescription":"BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue).\n\nA negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing BRAF-MDQ values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"From Baseline (Week 0) to Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"205" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"636" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-15.6", "OutcomeMeasurementSpread":"1.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-17.8", "OutcomeMeasurementSpread":"0.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "OutcomeMeasureDescription":"Number of work days missed in the last month for employed subjects.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"106" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"351" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.9", "OutcomeMeasurementSpread":"2.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.6", "OutcomeMeasurementSpread":"2.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "OutcomeMeasureDescription":"Number of work days with reduced productivity in the last month for employed subjects.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"106" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"351" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.8", "OutcomeMeasurementSpread":"4.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.0", "OutcomeMeasurementSpread":"3.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "OutcomeMeasureDescription":"The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"106" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"351" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.9", "OutcomeMeasurementSpread":"2.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.4", "OutcomeMeasurementSpread":"2.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "OutcomeMeasureDescription":"Number of days with no household work in the last month.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"206" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"640" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.0", "OutcomeMeasurementSpread":"6.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.9", "OutcomeMeasurementSpread":"5.1" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "OutcomeMeasureDescription":"Number of days with reduced household work productivity in the last month.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"206" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"640" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.0", "OutcomeMeasurementSpread":"6.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.1", "OutcomeMeasurementSpread":"5.3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "OutcomeMeasureDescription":"Number of days with hired outside help in the last month.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"206" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"640" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.7", "OutcomeMeasurementSpread":"3.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.6", "OutcomeMeasurementSpread":"3.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "OutcomeMeasureDescription":"Number of days missed of family/social/leisure activities in the last month.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"206" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"640" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.9", "OutcomeMeasurementSpread":"3.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.9", "OutcomeMeasurementSpread":"3.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52", "OutcomeMeasureDescription":"The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"206" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"640" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.5", "OutcomeMeasurementSpread":"2.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.9", "OutcomeMeasurementSpread":"2.5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52", "OutcomeMeasureDescription":"LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2.", "OutcomeMeasurePopulationDescription":"Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of subjects", "OutcomeMeasureTimeFrame":"Week 52", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Certolizumab Pegol + Methotrexate (Full Analysis Set)", "OutcomeGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"213" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"655" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"39.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"54.7" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse Events were collected from Screening over Baseline (Week 0) and Treatment Period 1 (Week 2 to Week 52) to the Safety Follow-Up Visit (Week 60).", "EventsDescription":"Adverse Events presented below refer to the Safety Set 1 (SS1), which consisted of all subjects in the Randomized Set who had received at least 1 dose of study medication (CZP/PBO) in Period 1.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Placebo + Methotrexate", "EventGroupDescription":"Placebo + Methotrexate (MTX)\n\n2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8.", "EventGroupSeriousNumAffected":"20", "EventGroupSeriousNumAtRisk":"217", "EventGroupOtherNumAffected":"63", "EventGroupOtherNumAtRisk":"217" },{ "EventGroupId":"EG001", "EventGroupTitle":"Certolizumab Pegol + Methotrexate", "EventGroupDescription":"Certolizumab Pegol + Methotrexate (MTX)\n\nPrefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.\n\nInjections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.\n\nThe MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8.", "EventGroupSeriousNumAffected":"70", "EventGroupSeriousNumAtRisk":"659", "EventGroupOtherNumAffected":"248", "EventGroupOtherNumAtRisk":"659" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Anaemia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Bone marrow toxicity", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Iron deficiency anaemia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Pancytopenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Acute myocardial infarction", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Atrial fibrillation", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Cardiac arrest", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Cardiac failure", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Cardiac tamponade", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Myocardial infarction", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Myocardial ischaemia", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Pericarditis", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Colitis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Duodenal ulcer", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Erosive duodenitis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Gastritis erosive", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Gastrointestinal ulcer haemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Gastrooesophageal reflux disease", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Mesenteric panniculitis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Mouth ulceration", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Nausea", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Pancreatitis acute", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Rectal haemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Upper gastrointestinal haemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Bile duct stone", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Cholecystitis", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Cholelithiasis", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Anaphylactic shock", "SeriousEventOrganSystem":"Immune system disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Food allergy", "SeriousEventOrganSystem":"Immune system disorders", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Abscess limb", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Appendiceal abscess", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Arthritis infective", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Breast abscess", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"659" } ] } },{ "SeriousEventTerm":"Bronchitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA17.0", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"217" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", 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