NCT00144586已完成3 期
An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA220JP or MRA221JP
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
- 42
- 主要终点
- 20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.
研究概览
简要总结
This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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)
结局指标
主要结局
20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.
时间窗: throughout study
次要结局
- Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.(Week 0, then every 4 Week)
研究者
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