PER-083-10已完成未知
A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active 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
- 18 至 90（—）
入选标准
- •Adult participants, ≥ 18 years of age
- •Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria
- •Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline
- •Inadequate response to current DMARD therapy
- •Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline
- •Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline
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 RA
- •Functional class IV (ACR classification)
- •Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16
- •Prior history of or current inflammatory joint disease other than RA
- •Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
- •Previous treatment with tocilizumab
- •Active current or history of recurrent infection
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