{ "FullStudy":{ "Rank":218250, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510769", "OrgStudyIdInfo":{ "OrgStudyId":"RDEA594-304" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-003768-55", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Ardea Biosciences, Inc.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat", "OfficialTitle":"A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects With Tophaceous Gout", "Acronym":"CRYSTAL" }, "StatusModule":{ "StatusVerifiedDate":"April 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 16, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 14, 2016", "ResultsFirstSubmitQCDate":"April 20, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"May 26, 2016", "ResultsFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"March 23, 2015", "DispFirstSubmitQCDate":"March 23, 2015", "DispFirstPostDateStruct":{ "DispFirstPostDate":"April 10, 2015", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"April 20, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 26, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Ardea Biosciences, Inc.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.", "DetailedDescription":"Febuxostat is an XO (Xanthine Oxidase) Inhibitor approved Urate Lowering Therapy (ULT) for patients with gout. Although febuxostat has been demonstrated to be superior to allopurinol in lowering serum urate (sUA) to < 6mg/dL in 3 randomized, controlled clinical trials, proportions of subjects experiencing a reduction in tophus area and gout flares were not significantly different compared to allopurinol. Although this study will allow subjects who are naïve to ULT to enroll, it is anticipated that the majority of subjects will currently be taking or have previously experienced XO Inhibitor therapy. This trial will enroll a population of subjects with high uric acid body burden, as all must demonstrate the presence of tophi." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Tophaceous Gout" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"330", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"lesinurad 400 mg + febuxostat 80 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Lesinurad", "Drug: Febuxostat" ] } },{ "ArmGroupLabel":"lesinurad 200 mg + febuxostat 80 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Lesinurad", "Drug: Febuxostat" ] } },{ "ArmGroupLabel":"placebo + febuxostat 80 mg", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo", "Drug: Febuxostat" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Lesinurad", "InterventionDescription":"Tablets, 400 mg once daily (QD)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "lesinurad 400 mg + febuxostat 80 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"Lesinurad", "InterventionDescription":"Tablets, 200 mg QD", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "lesinurad 200 mg + febuxostat 80 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Tablets, Placebo QD", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "placebo + febuxostat 80 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"Febuxostat", "InterventionDescription":"80 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "lesinurad 200 mg + febuxostat 80 mg", "lesinurad 400 mg + febuxostat 80 mg", "placebo + febuxostat 80 mg" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6", "PrimaryOutcomeDescription":"Proportion of subjects with an sUA level that is < 5.0 mg/dL by Month 6", "PrimaryOutcomeTimeFrame":"6 months, analysis after all subjects complete 12 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Complete Resolution of at Least One Target Tophus", "SecondaryOutcomeDescription":"Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12", "SecondaryOutcomeTimeFrame":"12 Months" },{ "SecondaryOutcomeMeasure":"Complete or Partial Response of at Least One Tophus", "SecondaryOutcomeDescription":"Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12", "SecondaryOutcomeTimeFrame":"12 Months" },{ "SecondaryOutcomeMeasure":"Quality of Life", "SecondaryOutcomeDescription":"Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12. The HAQ-DI assesses a patient's level of functional ability with items scores ranging from 0-3 with 0 being the least disability.", "SecondaryOutcomeTimeFrame":"12 Months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.\nSubject is willing to adhere to the visit/protocol schedules.\nSubject meets the diagnosis of gout as per the American Rheumatism Association\nCriteria for the Classification of Acute Arthritis of Primary Gout.\nSubject meets one of the following criteria:\nSubjects who are not currently taking an approved ULT must have an sUA value of ≥ 8 mg/dL (476 µmol/L).\nSubjects entering the study on a medically appropriate dose of febuxostat or allopurinol must have an sUA value of ≥ 6.0 mg/dL (357 µmol/L).\nSubject must be able to take gout flare prophylaxis with colchicine or non-steroidal anti-inflammatory drug (NSAID) (including Cox-2 selective NSAID) ± PPI.\nSubject with at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 20 mm in the longest diameter.\nBody mass index (BMI) < 45 kg/m2\n\nExclusion Criteria:\n\nSubject with known hypersensitivity or allergy to febuxostat.\nSubject who is taking any approved urate-lowering medication other than allopurinol or febuxostat that is indicated for the treatment of gout within 8 weeks of the Screening Visit.\nSubject who previously received pegloticase.\nSubject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).\nSubject with a history or suspicion of drug abuse within the past 5 years.\nSubject with a history of myositis/myopathy or rhabdomyolysis.\nSubject that requires or may require systemic immunosuppressive or immunomodulatory treatment.\nSubject with known or suspected human immunodeficiency virus (HIV) infection.\nSubject with a positive test for active hepatitis B or hepatitis C infection.\nSubject with a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.\nSubject within the last 12 months with: unstable angina, New York Heart Association thrombosis; or subjects currently receiving anticoagulants.\nSubject with uncontrolled hypertension.\nSubject with an estimated creatinine clearance < 30 mL/min.\nSubjects with a creatine kinase > 2.5 x ULN at any time during the Screening Period.\nSubject with active peptic ulcer disease requiring treatment.\nSubject with a history of xanthinuria, active liver disease, or hepatic dysfunction.\nSubject receiving chronic treatment with more than 325 mg of salicylates per day.\nSubject taking valpromide, progabide, or valproic acid.\nSubject who has received an investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit.\nSubject with any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"85 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Chris Storgard, MD", "OverallOfficialAffiliation":"Ardea Biosciences, Inc.", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Birmingham", "LocationState":"Alabama", "LocationZip":"35211", "LocationCountry":"United States" },{ "LocationCity":"Goodyear", "LocationState":"Arizona", "LocationZip":"85395", "LocationCountry":"United 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"LocationCountry":"Switzerland" },{ "LocationCity":"Fribourg", "LocationZip":"1708", "LocationCountry":"Switzerland" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"30616614", "ReferenceType":"derived", "ReferenceCitation":"Dalbeth N, Jones G, Terkeltaub R, Khanna D, Fung M, Baumgartner S, Perez-Ruiz F. Efficacy and safety during extended treatment of lesinurad in combination with febuxostat in patients with tophaceous gout: CRYSTAL extension study. Arthritis Res Ther. 2019 Jan 7;21(1):8. doi: 10.1186/s13075-018-1788-4." },{ "ReferencePMID":"28597604", "ReferenceType":"derived", "ReferenceCitation":"Dalbeth N, Jones G, Terkeltaub R, Khanna D, Kopicko J, Bhakta N, Adler S, Fung M, Storgard C, Baumgartner S, Perez-Ruiz F. Lesinurad, a Selective Uric Acid Reabsorption Inhibitor, in Combination With Febuxostat in Patients With Tophaceous Gout: Findings of a Phase III Clinical Trial. Arthritis Rheumatol. 2017 Sep;69(9):1903-1913. doi: 10.1002/art.40159. Epub 2017 Aug 4." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Related Info", "SeeAlsoLinkURL":"http://www.gouttrial.com" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"330 participants were randomized and 324 participants were included in the Intent-to-Treat (ITT) population (ie, 6 subjects were randomized but not treated).", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Lesinurad 200 mg + Febuxostat" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Lesinurad 400 mg + Febuxostat" },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Placebo + Febuxostat" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"106" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"109" },{ 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"FlowDropWithdrawType":"Gout Flare", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"11" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"10" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"9" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"5" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"5" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Lesinurad 200 mg + Febuxostat" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Lesinurad 400 mg + Febuxostat" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Placebo + Febuxostat" },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", 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"BaselineMeasurementValue":"54.1", "BaselineMeasurementSpread":"11.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureDescription":"<65 Years, >=65 Years", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"<65 Years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"89" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"90" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"89" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"268" } ] } } ] } },{ "BaselineClassTitle":">=65 Years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"56" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"15" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"100" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"102" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"107" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"309" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Australia", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"16" } ] } } ] } },{ "BaselineClassTitle":"Canada", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"17" } ] } } ] } },{ "BaselineClassTitle":"New Zealand", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"13" } ] } } ] } },{ "BaselineClassTitle":"Poland", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"32" } ] } } ] } },{ "BaselineClassTitle":"Switzerland", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"81" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"84" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"79" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"244" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6", "OutcomeMeasureDescription":"Proportion of subjects with an sUA level that is < 5.0 mg/dL by Month 6", "OutcomeMeasurePopulationDescription":"Intent-to-Treat Population", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Proportion of Subjects", "OutcomeMeasureTimeFrame":"6 months, analysis after all subjects complete 12 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lesinurad 200 mg + Febuxostat 80 mg", "OutcomeGroupDescription":"lesinurad 200 mg once daily (qd) plus febuxostat 80 mg" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lesinurad 400 mg + Febuxostat 80 mg", "OutcomeGroupDescription":"lesinurad 400 mg qd plus febuxostat 80 mg" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + Febuxostat 80 mg", "OutcomeGroupDescription":"placebo qd plus febuxostat 80 mg" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"106" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"109" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"109" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.566" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.761" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.468" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.1298", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"0.10", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.03", "OutcomeAnalysisCIUpperLimit":"0.23" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"0.29", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.17", "OutcomeAnalysisCIUpperLimit":"0.42" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Complete Resolution of at Least One Target Tophus", "OutcomeMeasureDescription":"Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12", "OutcomeMeasurePopulationDescription":"Intent-to-Treat Population", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Proportion of Subjects", "OutcomeMeasureTimeFrame":"12 Months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lesinurad 200 mg + Febuxostat 80 mg", "OutcomeGroupDescription":"lesinurad 200 mg once daily (qd) plus febuxostat 80 mg" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lesinurad 400 mg + Febuxostat 80 mg", "OutcomeGroupDescription":"lesinurad 400 mg qd plus febuxostat 80 mg" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + Febuxostat 80 mg", "OutcomeGroupDescription":"placebo qd plus febuxostat 80 mg" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"106" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"109" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"109" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.255" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.303" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.211" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.4453", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"0.04", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.07", "OutcomeAnalysisCIUpperLimit":"0.16" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.1149", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"0.09", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.02", "OutcomeAnalysisCIUpperLimit":"0.21" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Complete or Partial Response of at Least One Tophus", "OutcomeMeasureDescription":"Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12", "OutcomeMeasurePopulationDescription":"Intent-to-Treat Population", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Proportion of Subjects", "OutcomeMeasureTimeFrame":"12 Months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lesinurad 200 mg + Febuxostat 80 mg", "OutcomeGroupDescription":"lesinurad 200 mg once daily (qd) plus febuxostat 80 mg" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lesinurad 400 mg + Febuxostat 80 mg", "OutcomeGroupDescription":"lesinurad 400 mg qd plus febuxostat 80 mg" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + Febuxostat 80 mg", "OutcomeGroupDescription":"placebo qd plus febuxostat 80 mg" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"106" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"109" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"109" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.566" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.587" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.505" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.6450", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"0.03", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.10", "OutcomeAnalysisCIUpperLimit":"0.17" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.4118", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"0.06", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.08", "OutcomeAnalysisCIUpperLimit":"0.19" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Quality of Life", "OutcomeMeasureDescription":"Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12. The HAQ-DI assesses a patient's level of functional ability with items scores ranging from 0-3 with 0 being the least disability.", "OutcomeMeasurePopulationDescription":"Intent-to-Treat Population", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Proportion of Subjects", "OutcomeMeasureTimeFrame":"12 Months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Lesinurad 200 mg + Febuxostat 80 mg", "OutcomeGroupDescription":"lesinurad 200 mg once daily (qd) plus febuxostat 80 mg" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Lesinurad 400 mg + Febuxostat 80 mg", "OutcomeGroupDescription":"lesinurad 400 mg qd plus febuxostat 80 mg" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + Febuxostat 80 mg", "OutcomeGroupDescription":"placebo qd plus febuxostat 80 mg" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"77" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"78" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"80" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.442" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.333" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.525" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.3034", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"-0.08", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.24", "OutcomeAnalysisCIUpperLimit":"0.07" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0210", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"-0.19", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.34", "OutcomeAnalysisCIUpperLimit":"-0.04" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0.02", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Lesinurad 200 mg + Febuxostat", "EventGroupSeriousNumAffected":"6", "EventGroupSeriousNumAtRisk":"106", "EventGroupOtherNumAffected":"50", "EventGroupOtherNumAtRisk":"106" },{ "EventGroupId":"EG001", "EventGroupTitle":"Lesinurad 400 mg + Febuxostat", "EventGroupSeriousNumAffected":"9", "EventGroupSeriousNumAtRisk":"109", "EventGroupOtherNumAffected":"59", "EventGroupOtherNumAtRisk":"109" },{ "EventGroupId":"EG002", "EventGroupTitle":"Placebo + Febuxostat", "EventGroupSeriousNumAffected":"10", "EventGroupSeriousNumAtRisk":"109", "EventGroupOtherNumAffected":"34", "EventGroupOtherNumAtRisk":"109" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Acute myocardial infarction", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"106" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"109" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"109" } ] } },{ "SeriousEventTerm":"Angina pectoris", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"106" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"109" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"109" } ] } },{ "SeriousEventTerm":"Arrhythmia", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"106" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"109" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"109" } ] } },{ "SeriousEventTerm":"Atrial fibrillation", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"106" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"109" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"109" } ] } },{ "SeriousEventTerm":"Cardiac failure acute", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"106" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"109" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"109" } ] } },{ "SeriousEventTerm":"Cardiac failure congestive", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"106" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"109" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"109" } ] } },{ "SeriousEventTerm":"Coronary artery disease", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"106" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"109" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"109" } ] } },{ "SeriousEventTerm":"Pulseless electrical activity", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"106" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"109" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", 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