NCT01770834已完成不适用
A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.
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
- •Adult patients, >/= 21 years of age
- •Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2)
- •Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
- •Initiated on RoActemra/Actemra treatment in accordance with the prescribing information
排除标准
- •Pregnant or lactating women
- •Contra-indication to RoActemra/Actemra treatment according to the local labelling
- •Previous treatment with tocilizumab
- •Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- •Women of childbearing potential not using effective methods of contraception as defined by protocol
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: approximately 3 years
次要结局
- Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6)(approximately 3 years)
- Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment(approximately 3 years)
- Treatment regimens: Concomitant medications(approximately 3 years)
研究者
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