NCT01741688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
- 16
- 试验地点
- 4
- 主要终点
- Number of Participants on Tocilizumab at 6 Months After Treatment Initiation
研究概览
简要总结
This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in routine clinical practice in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment in accordance with the local label were 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
- •Adults, >/= 18 years of age
- •Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria
- •Participants in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label); this can include participants who have received tocilizumab treatment within 8 weeks prior to the enrollment visit
排除标准
- •Participants who have received tocilizumab more than 8 weeks prior to the enrollment visit
- •Participants who have 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
- •History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
结局指标
主要结局
Number of Participants on Tocilizumab at 6 Months After Treatment Initiation
时间窗: At 6 months
次要结局
- Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis(At baseline)
- Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure(At baseline)
- Number of Participants Starting Tocilizumab After Failing Other Biologic Agents(At baseline)
- Median Dose at 6 Months(At 6 months)
- Number of Participants With Dose Modifications at 6 Months(At 6 months)
- Median Duration of Treatment(Approximately 16 months)
- Percentage of Participants Discontinued From Tocilizumab for Safety(Approximately 16 months)
- Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy(Approximately 16 months)
- Number of Participants Discontinued From Tocilizumab for Other Reasons(Approximately 16 months)
- Time to Restoration of Initial Dosing Regimen(Approximately 16 months)
- Non-adherence Rate of Physician to the Recommended Dosing Regimen(Approximately 16 months)
- Percentage of Participants on Tocilizumab Monotherapy at Study Entry(At baseline)
- Total Tender Joint Count (TJC)(At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks)
- Total Swollen Joint Count (SJC)(At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks)
- Disease Activity Score Based on 28 Joints (DAS28)(At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks)
研究者
研究点 (4)
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