NCT01565122已完成不适用
An Observational, Non-interventional, Multi-national 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
- 51
- 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 clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.
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
- •Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011
排除标准
- •RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B
- •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 the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- •History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
结局指标
主要结局
Proportion of patients on RoActemra/Actemra treatment at 6 months
时间窗: approximately 2.5 years
次要结局
- Safety: Incidence of adverse events(approximately 2.5 years)
- Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR(approximately 2.5 years)
- Rates of dose modifications/interruptions(approximately 2.5 years)
- Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment(approximately 2.5 years)
- Efficacy: Monotherapy versus combination therapy(approximately 2.5 years)
- Quality of life: Patient global assessment of disease activity/VAS-Fatigue/VAS-Pain scales(approximately 2.5 years)
研究者
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