JPRN-jRCT2080221588未知2 期
A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of Clazakizumab Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.
Bristol-Myers K.K.0 个研究点目标入组 406 人开始时间: 2011年9月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 406
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
- >= 18age old 至 ot applicable（—）
- 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 7.5 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.
- •High sensitivity C-reactive protein (hsCRP) more than 0.8 mg/d
排除标准
- •Previously received or currently receiving concomitant biologic therapy.
研究者
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