EUCTR2009-011593-15-GB进行中（未招募）1 期
A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 188
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •children/juveniles, 2-17 years of age
- •polyarticular-course juvenile idiopathic arthritis (pcJIA) > / = 6 months duration
- •active disease (>/= 5 active joints, >/= 3 with limitation of motion)
- •inadequate response to or inability to tolerate methotrexate
- •methotrexate, oral corticosteroids and NSAIDs at stable dose (at least 8, 4 and 2 weeks, respectively) prior to and including baseline
- •biologics discontinued, between at least 1 and 20 weeks prior to and including baseline, depending on biologic
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •auto-immune, rheumatic disease or overlap syndrome other than polyarticular-course JIA
- •wheelchair bound or bedridden
- •intraarticular, intramuscular, intravenous or long-acting corticosteroids
- •within 4 weeks prior to and including baseline
- •DMARDs (other than methotrexate) within 4 weeks prior to and
- •including baseline
- •previous treatment with tocilizumab
研究者
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已完成
不适用
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