Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 465
- 主要终点
- Proportion of patients with an ACR20 response
研究概览
简要总结
This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 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
2
干预措施: rituximab (Drug)
2
干预措施: corticosteroids (Drug)
3
干预措施: methotrexate (Drug)
3
干预措施: rituximab (Drug)
3
干预措施: corticosteroids (Drug)
1
干预措施: methotrexate (Drug)
1
干预措施: rituximab (Drug)
2
干预措施: methotrexate (Drug)
4
干预措施: methotrexate (Drug)
4
干预措施: rituximab (Drug)
5
干预措施: methotrexate (Drug)
5
干预措施: rituximab (Drug)
5
干预措施: corticosteroids (Drug)
6
干预措施: methotrexate (Drug)
6
干预措施: rituximab (Drug)
6
干预措施: corticosteroids (Drug)
7
干预措施: methotrexate (Drug)
7
干预措施: placebo (Drug)
8
干预措施: methotrexate (Drug)
8
干预措施: corticosteroids (Drug)
8
干预措施: placebo (Drug)
9
干预措施: methotrexate (Drug)
9
干预措施: corticosteroids (Drug)
9
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of patients with an ACR20 response
时间窗: 24 weeks
次要结局
- Proportion of patients with ACR(50,70) responses(24 weeks)
- Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups(24 weeks)