[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100135211":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":39,"centralContacts":27,"locations":43,"responsibleParty":408,"collaborators":27,"id":410,"slug":411,"hasResults":412,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":418,"sex":419,"minAge":420,"maxAge":421,"enrollmentInfo":422,"targetDuration":27,"studyType":425,"phases":426,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":435,"whyStopped":27,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":445},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Canakinumab 150 mg","EXPERIMENTAL","Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive re-dose of study drug on demand upon occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after previous dose. Patients completing 12 weeks core study were allowed to continue treatment in another 12-week extension for any new gout flare on demand with same treatment as assigned in core study.\n\nAfter completing the first extension, patients were offered to enter second extension study, whereby all patients were treated open-label \"on demand\" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in core study. Patients completing first 12 weeks extension study were allowed to continue to be treated in another single-arm, open-label 48 weeks extension when all patients from both treatment arms received canakinumab on demand",[13,14],"Drug: Canakinumab 150 mg","Drug: Placebo to triamcinolone acetonide",{"label":16,"type":17,"description":18,"interventionNames":19},"Triamcinolone acetonide 40 mg","ACTIVE_COMPARATOR","Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.\n\nPatients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period Triamcinolone acetonide was not to be administered in the 48-week session.",[20,21],"Drug: Triamcinolone acetonide 40 mg","Drug: Placebo to canakinumab",[23,28,31,35],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).",[9],null,{"type":24,"name":16,"description":29,"armGroupLabels":30,"otherNames":27},"Triamcinolone acetonide 40 mg was supplied as a suspension.",[16],{"type":24,"name":32,"description":33,"armGroupLabels":34,"otherNames":27},"Placebo to 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in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and\u002For Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study","A 12 Weeks Randomized, Controlled Core Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and\u002For Colchicine Are Contraindicated, Not Tolerated or Ineffective, Including a 12-week Double-blind Extension Study and an Open-label 48 Week Extension Study","β-RELIEVED","Core Study:\n\nInclusion criteria:\n\n* Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout\n* Onset of current acute gout flare within 5 days prior to study entry\n* Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)\n* History of ≥ 3 gout flares within the 12 months prior to study entry\n* Contraindication, intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAIDs) and\u002For colchicine\n\nExclusion criteria:\n\n* Rheumatoid arthritis, evidence\u002Fsuspicion of infectious\u002Fseptic arthritis, or other acute inflammatory arthritis\n* Presence of severe renal function impairment\n* Use of specified pain relief medications or biologics ( corticosteroids, narcotics, paracetamol\u002Facetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor) within specified periods prior to study entry\n* Live vaccinations within 3 months prior to randomization\n* Requirement for administration of antibiotics against latent tuberculosis (TB)\n* Refractory heart failure (Stage D)\n* Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia\n* Any active or recurrent bacterial, fungal, or viral infection\n\nExtension Study 1:\n\nInclusion Completion of the Core study. A patient was defined as completing the core study if they completed the study up to and including visit 7.\n\nExclusion\n\n\\- Continuation in this extension study was considered inappropriate by the treating physician.\n\nExtension Study 2:\n\nInclusion Completed of the first extension study CACZ885H2356E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10).\n\nExclusion\n\n-Continuation in this extension study was considered inappropriate by the treating physician\n\nOther protocol-defined inclusion-exclusion criteria applied to the core and extension studies.",false,"ALL","18 Years","85 Years",{"count":423,"type":424},230,"ACTUAL","INTERVENTIONAL",[427],"PHASE3","The purpose of the 12-week core study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and\u002F or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide.\n\nThe purpose of the first 12-week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2356.\n\nThe purpose of the second 48 week open-label extension study was to collect additional long-term safety and tolerability data in patients who have completed the first extension study CACZ885H2356E1.",[430],"Acute Gout",[432,433,434],"frequent flares","gout","anti-interleukin-1β monoclonal antibody","COMPLETED","2013-12-24",{"date":438,"type":439},"2014-01-30","ESTIMATED",{"date":441,"type":27},"2009-12",{"date":443,"type":424},"2010-10",{"name":41,"class":6},47]