Still's Disease, Adult-Onset Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of Subcutaneous Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
A study to demonstrate efficacy and safety of anakinra in pediatric and adult Japanese patients with Still's disease (Systemic juvenile idiopathic arthritis [SJIA] and Adult-onset Still's disease [AOSD]).
The study consists of a 2-Week, randomized, double-blind, placebo-controlled period, followed by a 52-Week open-label phase treatment with anakinra. After the last dose of anakinra at Week 54, the safety will be evaluated at a Safety Follow-up visit i.e., at Week 58. The primary endpoint will be evaluated at Week 2 visit. Patients will be randomly assigned to either anakinra or placebo for a period of 2 weeks. ;
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