EUCTR2007-000872-18-GB进行中（未招募）1 期
A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
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
- •patients aged 2 - 17 years of age;
- •systemic JIA with >= 6 months persistent activity;
- •presence of active disease (>= 5 active joints, or >= 2 active joints + fever + steroids);
- •inadequate clinical response to NSAIDs and corticosteroids due to toxicity or lack of efficacy.
- •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
- •wheelchair bound or bed-ridden;
- •any other autoimmune, rheumatic disease or overlap syndrome other than sJIA;
- •intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study;
- •DMARDs (other than methotrexate);
- •previous treatment with tocilizumab.
研究者
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