NCT01283399已完成不适用
A Non-interventional Multicenter Study of MabThera® (Rituximab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 主要终点
- Disease Activity Score Based on 28-joints Count (DAS28)
研究概览
简要总结
This observational study will assess the efficacy and safety of combination of rituximab (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA) who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in routine clinical practice. Data will be collected from participants for 12 months after the first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active rheumatoid arthritis
- •Inadequate response to a single TNF inhibitor
- •Participants receiving rituximab therapy in accordance with the prescribing information
- •Signed data release form within 6 weeks (42 days) of initiating rituximab therapy
- •Women of childbearing potential must use effective form of contraception
排除标准
- •Contra-indication to receive rituximab according to the local labelling
- •Previous treatment with rituximab
- •Treatment with any investigational drug within 30 days prior to enrolment
结局指标
主要结局
Disease Activity Score Based on 28-joints Count (DAS28)
时间窗: Up to 5 years
次要结局
- Reasons for Re-treatment With Rituximab Within 6 Months of the First Treatment(Up to 5 years)
- Disease Activity Score Based on 28-joints Count (DAS28) 6 Months After the Re-treatment With Rituximab(6 Months After the Re-treatment With Rituximab (up to 5 years))
- Demographics of Participants Eligible to Receive Rituximab(Baseline)
- Number of Participants With Adverse Events(5 years)
研究者
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