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Kingdom","UK",{"type":94,"coordinates":770},[771,772],-1.51217,52.40656,{"lat":772,"lon":771},{"facility":775,"status":64,"city":776,"state":64,"zip":64,"country":767,"countryCode":768,"cosmosGeoPoint":64,"geoPoint":64,"contacts":64},"Flyde Coast Clinical Research Ltd","Lancashire",{"type":778,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100119323","phase-2-a-study-of-the-efficacy-of-canakinumab-in-prevention-of-acute-flares-in-chronic-gout-patients-initiating-allopurinol-therapy-core-study-and-a-long-term-study-of-the-efficacy-and-safety-of-canakinumab-in-patients-with-gout-extension-study-100119323",true,"NCT00819585","A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)","A 24-week, Dose-ranging, Multicenter, Double-blind, Double-dummy, Active-controlled Core Study to Evaluate Canakinumab for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy and a 24-week Open-label, Multicenter Extension Study to Assess Safety, Tolerability and Efficacy of Canakinumab in Patients With Gout Who Are Given Canakinumab at the Time of Gout Flare","Core study\n\nInclusion Criteria:\n\n* Signed written informed consent before any study procedure is performed.\n* History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.\n* Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.\n* Body Mass Index (BMI) ≤ 40 kg\u002Fm\\^2.\n* Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped \\> 2 months before Screening (Visit 1) for reasons different to toxicity\u002F intolerance or lack of efficacy.\n\nExclusion Criteria:\n\n* Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.\n* History of allergy or contraindication to colchicine or allopurinol.\n* History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.\n* History of bone marrow suppression.\n* Absolute or relative contraindication to both naproxen and oral prednisolone\u002F prednisone.\n\nExtension study\n\nInclusion criteria:\n\n* Patients who completed the core study. A patient is defined as completing the core study if he\u002Fshe completed the study up to and including the last visit (Visit 9).\n* Patients who have signed a written informed consent before any trial procedure is performed.\n\nExclusion Criteria:\n\n* Patients for whom continuation in the extension study is not considered appropriate by the treating physician.\n* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).\n\nOther protocol-defined inclusion\u002Fexclusion criteria applied to the study.",false,"ALL","18 Years","80 Years",{"count":791,"type":792},432,"ACTUAL","INTERVENTIONAL",[795],"PHASE2","The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.",[798],"Gout",[798,800,801,802],"Chronic gout","Gouty arthritis","Gout flares","COMPLETED","2018-06-19",{"date":806,"type":792},"2018-07-17",{"date":808,"type":64},"2008-12",{"date":810,"type":792},"2010-08",{"name":83,"class":6},89]