{"groups":[{"description":"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants 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. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.\n\nIn the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months.","id":"FG000","title":"Canakinumab 150 mg"},{"description":"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants 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.\n\nIn the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.\n\nIn the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study.","id":"FG001","title":"Triamcinolone Acetonide 40 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Abnormal laboratory value(s)"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}],"type":"Patient withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Protocol deviation"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"112"},{"groupId":"FG001","numSubjects":"114"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"99"},{"groupId":"FG001","numSubjects":"103"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"11"}],"type":"NOT COMPLETED"}],"title":"Core Study (0- 12 Weeks)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Unsatisfactory Therapeutic Effect"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"84"},{"groupId":"FG001","numSubjects":"76"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"72"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Extension Study 1 (12 -24 Weeks)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"72"},{"groupId":"FG001","numSubjects":"65"}],"type":"STARTED"},{"achievements":[{"comment":"Includes patients re-treated with canakinumab at any time during the 72 weeks","groupId":"FG000","numSubjects":"62"},{"comment":"Includes patients switched to canakinumab from Week 25 - Week 72","groupId":"FG001","numSubjects":"41"}],"type":"Re-treated With or Switch to Canakinumab"},{"achievements":[{"groupId":"FG000","numSubjects":"64"},{"groupId":"FG001","numSubjects":"54"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"11"}],"type":"NOT COMPLETED"}],"title":"Extension Study 2 (25-72 Weeks)"}]}