NCT00934648已完成4 期
An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Percentage of Participants With an Adverse Event (AE)
研究概览
简要总结
This study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=18 years of age;
- •receiving out-patient treatment;
- •experienced an inadequate response to previous or current treatment with methotrexate.
排除标准
- •rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
- •history of, or current, inflammatory joint disease other than RA;
- •previous treatment with any cell-depleting therapies.
研究组 & 干预措施
1
Experimental
干预措施: rituximab [MabThera/Rituxan] (Drug)
1
Experimental
干预措施: methotrexate (Drug)
结局指标
主要结局
Percentage of Participants With an Adverse Event (AE)
时间窗: Week 104
次要结局
- Disease Activity Score Based on 28-Joint Count (DAS28)(Day 1 and Week 24)
- Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category(Screening, Day 1, and Weeks 24 and 104)
- Percentage of Participants With Changes in Bone Density(Screening, Weeks 48 and 104)
研究者
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