EUCTR2010-023956-99-ES进行中（未招募）不适用
A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - Site Specific (v1.0, dated 11-Jan-2011);Protocol Amendment 03 (v1.0, dated 08-Mar-2011)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 677
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
- •? Inadequate response to methotrexate
- •? Must have been taking methotrexate for at least 3 months at a minimal weekly dose of 15 mg and stable dose for 4 weeks prior to randomization
- •? ACR global function status class 1-3
- •? Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist
- •? hsCRP >/= 0.8 mg/dL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 476
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 201
排除标准
- •? Previously received or currently receiving concomitant biologic therapy
研究者
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