NCT00144521已完成3 期
A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- Frequency of ACR 20% improvement
研究概览
简要总结
The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: MRA(Tocilizumab) (Drug)
1
Experimental
干预措施: MTX placebo (Drug)
2
Active Comparator
干预措施: MRA placebo (Drug)
2
Active Comparator
干预措施: MTX (Drug)
结局指标
主要结局
Frequency of ACR 20% improvement
时间窗: week 24
次要结局
- Frequency and severity of adverse events and adverse drug reactions(throughout study)
- Time course of DAS28(throughout study)
- time course of the frequency of ACR 20%, 50% and 70%(throughout study)
研究者
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