NL-OMON41649已完成3 期
Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial. - Bio-sequetia RA study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
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 99（—）
入选标准
- •Adult patients, between 18 and 80 years of age, with moderately to severely active RA for at least 6 months as defined by at least six swollen joints (66 joint count) and at least eight tender joints (68 joint count) at Screening and Baseline (Day 1), and either an erythrocyte sedimentation rate (ESR) of > 28 mm/hour OR a C-reactive protein (CRP) level > 1.0 mg/dL (normal: < 0.4 mg/dL) at Screening. Patients must have had an inadequate response or intolerance to conventional disease modifying anti-rheumatic drug (DMARD) therapy including at least one tumor necrosis factor (TNF) inhibitor.
- •Must be currently receiving and tolerating oral or parenteral therapy at a dose of 15-25 mg per week (dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose) for at least 12 weeks immediately prior to Day 1. The dose should be stable for at least 4 weeks prior to Day 1 (for all inclusion criteria see also page 35-36 of the protocol).
排除标准
- •Patients with active infection, severe immunosuppression or severe heart failure will be excluded (for all exclusion criteria see page 36-38 of the protocol).
研究者
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