PER-144-09已完成未知
A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 80（—）
入选标准
- •Adult patients ≥ 18 years of age.
- •Rheumatoid arthritis of ≤ 2 years duration.
- •Disease Activity Score 28 (DAS28) > 3.2.
- •Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints.
- •Rheumatoid factor (RF) and/or anti−cyclic citrullinated peptide (anti-CCP) positive (if RF and anti-CCP negative > 1 erosion required at screening).
- •Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/L at screening.
排除标准
- •Previous treatment with tocilizumab.
- •Previous treatment with methotrexate or biologic agent.
- •Rheumatic autoimmune disease other than rheumatoid arthritis (RA).
- •History of or current inflammatory joint disease other than RA.
- •Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in RA.
研究者
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