EUCTR2010-019912-18-BG进行中（未招募）不适用
A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- 性别
- All
入选标准
- •- Adult patients, >/=18 years of age
- •- Moderate to severe rheumatoid arthritis of >/=6 months duration
- •- Receiving treatment on an outpatient basis
- •- Swollen joint count (SJC) >/=6 (66 joint count) and tender joint count (TJC) >/=8 (68 joint count) at screening and study start
- •- On a stable dose of disease-modifying antirheumatic drugs for at least 8 weeks prior to study start
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 480
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
- •- Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's syndrome with rheumatoid arthritis is allowed
- •- Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
- •- Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years
- •- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
研究者
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