{ "FullStudy":{ "Rank":217794, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516749", "OrgStudyIdInfo":{ "OrgStudyId":"11-08101" }, "Organization":{ "OrgFullName":"University of California, San Francisco", "OrgClass":"OTHER" }, "BriefTitle":"Anakinra as a Treatment for Hydradenitis Suppurativa", "OfficialTitle":"An Open Label Non-randomized Study Assessing the Efficacy and Tolerability of Fixed-dose Regimen Daily Subcutaneous Anakinra for the Treatment of Moderate to Severe Hidradenitis Suppurativa" }, "StatusModule":{ "StatusVerifiedDate":"August 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"October 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 7, 2011", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"July 11, 2014", "ResultsFirstSubmitQCDate":"July 11, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"August 6, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 15, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 20, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"University of California, San Francisco", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This is an open-label, proof-of-concept research study to assess the effectiveness of anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned intervention is to provide about 6 HS patients with anakinra 100mg daily injections to administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for relapse of HS." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hidradenitis Suppurativa" ] }, "KeywordList":{ "Keyword":[ "hidradenitis suppurativa", "anakinra" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"6", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Anakinra", "ArmGroupType":"Experimental", "ArmGroupDescription":"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: anakinra" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"anakinra", "InterventionDescription":"Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Anakinra" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Kineret[TM]" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in Modified Sartorius Score", "PrimaryOutcomeDescription":"At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: < 5 cm, 1 point; 5-10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points.\n\nRegional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity.", "PrimaryOutcomeTimeFrame":"Baseline, 8 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in Quality of Life Assessments", "SecondaryOutcomeDescription":"The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable).\n\nThe Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked \"What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit?\" with a scale of 0=no acitivity to 100=maximal activity.", "SecondaryOutcomeTimeFrame":"Baseline, 8 weeks" },{ "SecondaryOutcomeMeasure":"Change in Dermatology Quality of Life Index (DLQI)", "SecondaryOutcomeDescription":"Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life", "SecondaryOutcomeTimeFrame":"Baseline, 8 weeks" },{ "SecondaryOutcomeMeasure":"Change in C-reactive Protein", "SecondaryOutcomeDescription":"Change assessed from baseline to end of treatment phase.", "SecondaryOutcomeTimeFrame":"Baseline, 8 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n1) Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with moderate or severe disease activity\n\nExclusion Criteria:\n\nUse of the following therapies:\n\nEtanercept in the 4 weeks prior to the baseline visit (Day 1)\nAdalimumab in the 8 weeks prior to the baseline visit (Day 1)\nInfliximab in the 12 weeks prior to the baseline visit (Day 1)\nAny other investigational biologics in the 8 weeks prior to the baseline visit (Day 1)\nLeflunomide in the 4 weeks prior to the baseline visit (Day 1) • Thalidomide in the 4 weeks prior to the baseline visit (Day 1)\nCyclosporine in the 4 weeks prior to the baseline visit (Day 1)\nI.V. immunoglobulin (I.V. Ig) in the 8 weeks prior to the baseline visit (Day 1)\n6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1)\nColchicine, dapsone, mycophenolate mofetil & systemic antibiotics in the 3 weeks prior to the baseline visit (Day 1)\nCorticosteroids \"20mg/day or >0.4 mg/kg, whichever applies, in the 1 week prior to the baseline visit (Day 1)\nhistory of immunocompromise including HIV infection\npositive Hep B surface antigen -", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Kieron S Leslie, M.D.", "OverallOfficialAffiliation":"University of California, San Francisco - Department of Dermatology", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"San Francisco General Hospital", "LocationCity":"San Francisco", "LocationState":"California", "LocationZip":"94110", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"18674845", "ReferenceType":"background", "ReferenceCitation":"Revuz JE, Canoui-Poitrine F, Wolkenstein P, Viallette C, Gabison G, Pouget F, Poli F, Faye O, Roujeau JC, Bonnelye G, Grob JJ, Bastuji-Garin S. Prevalence and factors associated with hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol. 2008 Oct;59(4):596-601. doi: 10.1016/j.jaad.2008.06.020." },{ "ReferencePMID":"2934550", "ReferenceType":"background", "ReferenceCitation":"Fitzsimmons JS, Guilbert PR. A family study of hidradenitis suppurativa. J Med Genet. 1985 Oct;22(5):367-73." },{ "ReferencePMID":"16093838", "ReferenceType":"background", "ReferenceCitation":"Stojanov S, Kastner DL. Familial autoinflammatory diseases: genetics, pathogenesis and treatment. Curr Opin Rheumatol. 2005 Sep;17(5):586-99. Review." },{ "ReferencePMID":"17039195", "ReferenceType":"background", "ReferenceCitation":"Steinhoff JP, Cilursu A, Falasca GF, Guzman L, Reginato AJ. A study of musculoskeletal manifestations in 12 patients with SAPHO syndrome. J Clin Rheumatol. 2002 Feb;8(1):13-22." },{ "ReferencePMID":"15897171", "ReferenceType":"background", "ReferenceCitation":"Rosi YL, Lowe L, Kang S. Treatment of hidradenitis suppurativa with infliximab in a patient with Crohn's disease. J Dermatolog Treat. 2005 Feb;16(1):58-61." },{ "ReferencePMID":"18241264", "ReferenceType":"background", "ReferenceCitation":"Hunger RE, Surovy AM, Hassan AS, Braathen LR, Yawalkar N. Toll-like receptor 2 is highly expressed in lesions of acne inversa and colocalizes with C-type lectin receptor. Br J Dermatol. 2008 Apr;158(4):691-7. doi: 10.1111/j.1365-2133.2007.08425.x. Epub 2008 Jan 30." },{ "ReferencePMID":"15125785", "ReferenceType":"background", "ReferenceCitation":"Sakai A, Han J, Cato AC, Akira S, Li JD. Glucocorticoids synergize with IL-1beta to induce TLR2 expression via MAP Kinase Phosphatase-1-dependent dual Inhibition of MAPK JNK and p38 in epithelial cells. BMC Mol Biol. 2004 May 4;5:2." },{ "ReferencePMID":"17178985", "ReferenceType":"background", "ReferenceCitation":"Leslie KS, Lachmann HJ, Bruning E, McGrath JA, Bybee A, Gallimore JR, Roberts PF, Woo P, Grattan CE, Hawkins PN. Phenotype, genotype, and sustained response to anakinra in 22 patients with autoinflammatory disease associated with CIAS-1/NALP3 mutations. Arch Dermatol. 2006 Dec;142(12):1591-7." },{ "ReferencePMID":"19438453", "ReferenceType":"background", "ReferenceCitation":"Sartorius K, Emtestam L, Jemec GB, Lapins J. Objective scoring of hidradenitis suppurativa reflecting the role of tobacco smoking and obesity. Br J Dermatol. 2009 Oct;161(4):831-9. doi: 10.1111/j.1365-2133.2009.09198.x. Epub 2009 Apr 29." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"11 patients were screened for inclusion. 6 were eligible and were enrolled.", "FlowRecruitmentDetails":"Patients were recruited from an academic dermatology practice in San Francisco, CA; informed consent was obtained before study entry.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Anakinra", "FlowGroupDescription":"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.\n\nanakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Active Therapy", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"6" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"5" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" } ] } } ] } },{ "FlowPeriodTitle":"Follow-up Off Therapy", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"5" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"4" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Eligible per protocol criteria", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Anakinra", "BaselineGroupDescription":"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.\n\nanakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"6" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"37", "BaselineMeasurementLowerLimit":"27", "BaselineMeasurementUpperLimit":"41" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Initial modified Sartorius score", "BaselineMeasureDescription":"The following are recorded by the dermatologist: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of lesion if single) in each region: < 5 cm, 1 point; 5–10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points. Regional scores are added and summed up to the patient’s total score. The upper limit of the scale is open.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"units on a scale", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"78.5", "BaselineMeasurementLowerLimit":"42", "BaselineMeasurementUpperLimit":"95" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Initial C-reactive protein", "BaselineMeasureDescription":"Normal <3.1 mg/L", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mg/L", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"30.6", "BaselineMeasurementSpread":"23.03" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change in Modified Sartorius Score", "OutcomeMeasureDescription":"At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: < 5 cm, 1 point; 5-10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points.\n\nRegional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity.", "OutcomeMeasurePopulationDescription":"The 5 patients who completed 8 weeks of therapy", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"Baseline, 8 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Anakinra", "OutcomeGroupDescription":"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.\n\nanakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"5" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-34.8", "OutcomeMeasurementLowerLimit":"-62.05", "OutcomeMeasurementUpperLimit":"-7.56" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"Significance of decrease in modified Sartorius score from Baseline to 8 weeks", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.024", "OutcomeAnalysisPValueComment":"significance was accepted at p<0.05", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Quality of Life Assessments", "OutcomeMeasureDescription":"The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable).\n\nThe Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked \"What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit?\" with a scale of 0=no acitivity to 100=maximal activity.", "OutcomeMeasurePopulationDescription":"Patients who completed 8 weeks of therapy", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"Baseline, 8 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Anakinra", "OutcomeGroupDescription":"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.\n\nanakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"5" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Physician Global Assessment", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-45.8", "OutcomeMeasurementLowerLimit":"-69.5", "OutcomeMeasurementUpperLimit":"-22.1" } ] } } ] } },{ "OutcomeClassTitle":"Patient Global Assessment", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-35.6", "OutcomeMeasurementLowerLimit":"-61.4", "OutcomeMeasurementUpperLimit":"-9.83" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"Significance of reductions in Physican Global Assessment mean values between baseline and 8 weeks of therapy", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.006", "OutcomeAnalysisPValueComment":"Significance was accepted at p<0.05", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"Significance of reductions in Patient Global Assessment mean values between baseline and 8 weeks of therapy", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.019", "OutcomeAnalysisPValueComment":"Significance was accepted at p<0.05", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Dermatology Quality of Life Index (DLQI)", "OutcomeMeasureDescription":"Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life", "OutcomeMeasurePopulationDescription":"Patients who completed 8 weeks of therapy", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"Baseline, 8 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Anakinra", "OutcomeGroupDescription":"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.\n\nanakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"5" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-8.4", "OutcomeMeasurementLowerLimit":"-16.57", "OutcomeMeasurementUpperLimit":"-0.23" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in C-reactive Protein", "OutcomeMeasureDescription":"Change assessed from baseline to end of treatment phase.", "OutcomeMeasurePopulationDescription":"Patients who completed 8 weeks of therapy", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"mg/L", "OutcomeMeasureTimeFrame":"Baseline, 8 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Anakinra", "OutcomeGroupDescription":"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.\n\nanakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"5" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-16.7", "OutcomeMeasurementLowerLimit":"-36.14", "OutcomeMeasurementUpperLimit":"2.784" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"16 weeks: 8 weeks of study therapy, followed by an additional 8 weeks of follow-up off therapy", "EventsDescription":"Vital signs and physical examinations were undertaken at every visit. The investigators assessed adverse events throughout the study by direct patient query, observation by study personnel, and spontaneous patient reporting.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Anakinra", "EventGroupDescription":"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.\n\nanakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"6", "EventGroupOtherNumAffected":"6", "EventGroupOtherNumAtRisk":"6" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Painful injection site", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"All patients reported painful injection site reactions, which decreased in severity after a few weeks of treatment.", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"6" } ] } } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Kieron S. Leslie, MD", "PointOfContactOrganization":"University of California, San Francisco", "PointOfContactEMail":"lesliek@derm.ucsf.edu", "PointOfContactPhone":"415-206-4777" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000053590", "InterventionMeshTerm":"Interleukin 1 Receptor Antagonist Protein" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000018501", "InterventionAncestorTerm":"Antirheumatic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M25946", "InterventionBrowseLeafName":"Interleukin 1 Receptor Antagonist Protein", "InterventionBrowseLeafAsFound":"Anakinra", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M19188", "InterventionBrowseLeafName":"Antirheumatic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ARhu", "InterventionBrowseBranchName":"Antirheumatic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000017497", "ConditionMeshTerm":"Hidradenitis Suppurativa" },{ "ConditionMeshId":"D000016575", "ConditionMeshTerm":"Hidradenitis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000013543", "ConditionAncestorTerm":"Sweat Gland Diseases" },{ "ConditionAncestorId":"D000012871", "ConditionAncestorTerm":"Skin Diseases" },{ "ConditionAncestorId":"D000017192", "ConditionAncestorTerm":"Skin Diseases, Bacterial" },{ "ConditionAncestorId":"D000001424", "ConditionAncestorTerm":"Bacterial Infections" },{ "ConditionAncestorId":"D000012874", "ConditionAncestorTerm":"Skin Diseases, Infectious" },{ "ConditionAncestorId":"D000007239", "ConditionAncestorTerm":"Infection" },{ "ConditionAncestorId":"D000013492", "ConditionAncestorTerm":"Suppuration" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M18345", "ConditionBrowseLeafName":"Hidradenitis Suppurativa", "ConditionBrowseLeafAsFound":"Hidradenitis Suppurativa", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M17547", "ConditionBrowseLeafName":"Hidradenitis", "ConditionBrowseLeafAsFound":"Hidradenitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14906", "ConditionBrowseLeafName":"Sweat Gland Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18083", "ConditionBrowseLeafName":"Skin Diseases, Bacterial", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3303", "ConditionBrowseLeafName":"Bacterial Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14260", "ConditionBrowseLeafName":"Skin Diseases, Infectious", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14856", "ConditionBrowseLeafName":"Suppuration", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }