NCT01196780终止不适用
MabThera Post Marketing Observational Study in TNF-IR Patients to Assess Efficacy and Safety of REPeated Courses in routinE ClinicAl pracTice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,240
- 主要终点
- Efficacy: Change in Disease Activity Score - erythrocyte sedimentation rate (DAS28 - ESR)
研究概览
简要总结
This observational study will assess the efficacy and safety of MabThera/Rituxan (Rituximab) in patients with active rheumatoid arthritis who have had an inadequate response or are intolerant to anti-TNF therapy. Data will be collected from patients initiated on MabThera/Rituxan therapy according to standard of care in routine clinical practice. For each patient data will be collected for 92 weeks.
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
- 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
- •Active Rheumatoid Arthritis
- •Inadequate response to anti-TNF
- •Eligible for MabThera/Rituxan therapy according to physician's decision
排除标准
- •According to Summary of Product Characteristics
结局指标
主要结局
Efficacy: Change in Disease Activity Score - erythrocyte sedimentation rate (DAS28 - ESR)
时间窗: from baseline to Week 92
次要结局
- Safety: Incidence of adverse events(4 years)
研究者
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