NCT01615419已完成不适用
A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Proportion of patients on RoActemra/Actemra treatment at 6 months
研究概览
简要总结
This multi-center, observational study will evaluate the use in clinical practice and efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.
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
- •Moderate to severe rheumatoid arthritis , according to the revised ACR criteria
- •Patients initiated on RoActemra/Actemra treatment (in accordance with the local label) on their treating physicians decision
排除标准
- •RoActemra/Actemra treatment more than 8 weeks prior to enrolment visit
- •Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
- •Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- •History of autoimmune disease or of any joint inflammatory disease other than RA
结局指标
主要结局
Proportion of patients on RoActemra/Actemra treatment at 6 months
时间窗: approximately 2 years
次要结局
- Efficacy: Monotherapy versus combination therapy(approximately 2 years)
- Rates of dose modifications/interruptions(approximately 2 years)
- Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR(approximately 2 years)
- Use of disease-modifying anti-rheumatic drugs (DMARDs)(approximately 2 years)
- Clinical/demographic patient characteristics at initiation of treatment(approximately 2 years)
研究者
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