NCT01649817已完成不适用
Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION II Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 主要终点
- Percentage of patients on RoActemra/Actemra at 6 months after initiating treatment
研究概览
简要总结
This multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be collected from each eligible patient over a period of 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Moderate to severe rheumatoid arthritis according to the revised 1987 ACR criteria at baseline
- •RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing
- •Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis
排除标准
- •Rheumatic autoimmune disease other than RA
- •Participation in interventional clinical trials during the observational period
结局指标
主要结局
Percentage of patients on RoActemra/Actemra at 6 months after initiating treatment
时间窗: 12 months
次要结局
- Frequency of withdrawal (according to reasons)(12 months)
- Frequency of dose modifications(12 months)
- Change in disease activity (DAS28)(from baseline to Month 6 or withdrawal, whichever comes first)
研究者
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