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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 Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.","A Randomized, Controlled 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 Weeks Extension Study and a 1 Year Open-label Extension Study","β-RELIEVED-II","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, or intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAID) 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:\n\n\\- 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 Criteria:\n\n* Completion of the first extension study CACZ885H2357E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10).\n\nExclusion Criteria:\n\n-Continuation in this second 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":982,"type":983},226,"ACTUAL","INTERVENTIONAL",[986],"PHASE3","The purpose of this 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 CACZ885H2357.\n\nThe purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.",[989],"Acute Gout",[991,992,993],"Frequent flares","Gout","Anti-interleukin-1β monoclonal antibody","COMPLETED","2013-12-24",{"date":997,"type":998},"2014-01-30","ESTIMATED",{"date":1000,"type":27},"2010-03",{"date":1002,"type":983},"2011-10",{"name":41,"class":6},108]