{"groups":[{"description":"In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \\>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.","id":"FG000","title":"Canakinumab"},{"description":"Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a \\>0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.","id":"FG001","title":"Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"72"},{"groupId":"FG001","numSubjects":"0"}],"type":"Unsatisfactory therapeutic effect"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"177"},{"comment":"No participants received placebo in Part I.","groupId":"FG001","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"145"},{"groupId":"FG001","numSubjects":"0"}],"type":"Entered Part Ia"},{"achievements":[{"groupId":"FG000","numSubjects":"142"},{"groupId":"FG001","numSubjects":"0"}],"type":"Entered Part Ib"},{"achievements":[{"comment":"Patients steroid free at study entry entered Part Id directly and did not participate in Part Ic.","groupId":"FG000","numSubjects":"92"},{"groupId":"FG001","numSubjects":"0"}],"type":"Entered Part Ic"},{"achievements":[{"groupId":"FG000","numSubjects":"103"},{"groupId":"FG001","numSubjects":"0"}],"type":"Entered Part 1d"},{"achievements":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Part I: Open Label"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"20"}],"type":"Unsatisfactory therapeutic effect"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol deviation"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"50"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"24"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"26"}],"type":"NOT COMPLETED"}],"title":"Part II: Randomized Double Blind"}]}