{"groups":[{"description":"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 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\nAfter completing the first extension study, patients were offered to enter the 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 the core study","id":"FG000","title":"Canakinumab 150 mg"},{"description":"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. No patient received triamcinolone acetonide in second extension Study .","id":"FG001","title":"Triamcinolone Acetonide 40 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}],"type":"Unsatisfactory therapeutic effect"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Patient Withdrew Consent"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"115"},{"groupId":"FG001","numSubjects":"115"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"113"},{"groupId":"FG001","numSubjects":"115"}],"type":"Full Analysis Set (FAS), Safety Set"},{"achievements":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"105"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"10"}],"type":"NOT COMPLETED"}],"title":"Core Study (0-12 Weeks)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Unsatisfactory therapeutic effect"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"90"},{"groupId":"FG001","numSubjects":"85"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"87"},{"groupId":"FG001","numSubjects":"80"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"}],"type":"NOT COMPLETED"}],"title":"Extension Study 1 (12-24 Weeks)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Unsatisfactory therapeutic effect"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"69"},{"groupId":"FG001","numSubjects":"66"}],"type":"STARTED"},{"achievements":[{"comment":"Includes patients re-treated with canakinumab over 72 weeks study duration overall","groupId":"FG000","numSubjects":"69"},{"comment":"Includes patients switched to canakinumab from Week 25 - Week 72","groupId":"FG001","numSubjects":"39"}],"type":"Re-treated With or Switch to Canakinumab"},{"achievements":[{"groupId":"FG000","numSubjects":"68"},{"groupId":"FG001","numSubjects":"63"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"Extension Study 2 (25-72 Weeks)"}],"preAssignmentDetails":"Two patients randomized to canakinumab did not receive any study medication and were discontinued from the core study on the day of randomization, with the reason for discontinuation listed as Administrative Problems."}