NCT01671059已完成不适用
A Multi-Center, Non-Interventional Study to Evaluate Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACROSS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation
研究概览
简要总结
This non-interventional study evaluated the use and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment according to the approved 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
- •Adult participants, >/= 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 made the decision to commence tocilizumab treatment (in accordance with the local label); this could include participants who had received tocilizumab treatment within 8 weeks prior to the enrollment visit
排除标准
- •Participants who had received tocilizumab more than 8 weeks prior to the enrollment visit
- •Participants who had previously received tocilizumab 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 was 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
Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation
时间窗: 6 months
次要结局
- Percentage of Participants With Dose Modifications(6 months)
- Percentage of Participants on Monotherapy Achieving a Response by European League Against Rheumatism (EULAR) Category(6 months)
- Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs)(6 months)
- Reasons for Dose Modifications(6 months)
- Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents(Baseline)
- Percentage of Participants With Dose Interruptions(6 months)
- Simplified Disease Activity Index (SDAI)(6 months)
- Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy(6 months)
- Percentage of Participants on Tocilizumab Monotherapy at Study Entry(6 months)
- Percentage of Participants on Combination Therapy Achieving a Response by European League Against Rheumatism (EULAR) Category(6 months)
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)(6 months)
- Health Assessment Questionnaire Disability Index (HAQ-DI)(6 months)
- Disease Activity Score Based on 28-Joint Count (DAS28)(6 months)
- Patient Global Assessment of Disease Activity Score(6 months)
- Clinical Disease Activity Index (CDAI) Score(6 months)
- Percentage of Participants With American College of Rheumatology (ACR) Response(6 months)
- Visual Analogue Scale (VAS) for Fatigue(6 months)
- Visual Analogue Scale (VAS) for Morning Stiffness(6 months)
- Visual Analogue Scale (VAS) for Pain(6 months)
研究者
研究点 (5)
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