NCT01613378已完成不适用
A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Who Are Treated With Tocilizumab
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
研究概览
简要总结
This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients initiated on treatment with tocilizumab according to the licensed Canadian product monograph recommendations will be followed for 12 months from the 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 according to revised (1987) American college of rheumatology (ACR) criteria
- •Initiated on tocilizumab treatment by the treating physician in accordance with the Canadian product monograph
- •Informed consent to data being subject to computerized data processing
- •Participant must fulfill the reimbursement criteria for treatment with tocilizumab under provincial or private health insurance coverage
排除标准
- •Received tocilizumab prior to enrolment visit
- •Previously received tocilizumab in a clinical trial or for compassionate use
- •Enrolled in an ongoing clinical trial and/or received treatment with any investigational agent within 4 weeks, or 5 half-lives of the investigational agent, whichever is longer, before starting treatment with tocilizumab
- •Participation in another clinical trial or industry sponsored observational study
- •History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome
结局指标
主要结局
Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
时间窗: At 6 months
次要结局
- Change From Baseline in C-Reactive Protein (CRP)(From baseline to Month 12)
- Change From Baseline in Tender Joint Count (TJC)(From baseline to Month 12)
- Change From Baseline in Disease Activity Score 28 (DAS28)(From baseline to Month 12)
- Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months(At 12 months)
- Change From Baseline in Swollen Joint Count (SJC)(From baseline to Month 12)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(From baseline to Month 12)
- Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)(From baseline to Month 12)
- Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS)(From baseline to Month 12)
- Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS)(From baseline to Month 12)
- Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months(At 12 months)
- Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)(From baseline to Month 12)
- Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS)(From baseline to Month 12)
研究者
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