An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- AEs, including infusion-related adverse events
研究概览
简要总结
This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-80 years of age;
- •moderate to severe active rheumatoid arthritis;
- •inadequate response to previous or current treatment with 1 anti-TNF agent;
- •receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for >=4 weeks.
排除标准
- •previous treatment with MabThera;
- •use of an anti-TNF alpha agent within 8 weeks of study start;
- •concurrent treatment with any DMARD other than methotrexate;
- •active infection, or history of serious recurrent or chronic infection.
研究组 & 干预措施
1
干预措施: Methotrexate (Drug)
1
干预措施: rituximab [MabThera/Rituxan] (Drug)
结局指标
主要结局
AEs, including infusion-related adverse events
时间窗: For 48 weeks after initial treatment
次要结局
- Laboratory parameters, vital signs.(Throughout study)
- ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.(For 48 weeks after initial treatment.)
- Safety of re-treatment (AEs)(For 24 weeks after re-treatment.)