NCT01075477已完成不适用
Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 主要终点
- Efficacy: DAS28
研究概览
简要总结
This observational study will assess the execution, efficacy and safety of treatment with MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera according to local treatment guidelines will be collected for 29 months. Target sample size is 100-200 patients.
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
- •rheumatoid arthritis
- •treatment with rituximab
排除标准
- •unable/unwilling to give informed consent to data collection
研究组 & 干预措施
Cohort
干预措施: rituximab [Mabthera/Rituxan] (Drug)
结局指标
主要结局
Efficacy: DAS28
时间窗: 29 months
次要结局
- Safety: serious and non-serious adverse events(29 months)
- Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS)(29 months)
研究者
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