A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation
研究概览
简要总结
This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed 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 (1987) ACR criteria
- •Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label (DMARD-IR, TNF-IR or need of RoActemra/Actemra monotherapy); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
排除标准
- •Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
- •Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
- •Patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- •Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
研究组 & 干预措施
Rheumatoid Arthritis Participants
Participants with moderate to severe rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score based on 28 Joint Count (DAS28) who were on tocilizumab treatment within 8 weeks prior to start of study will receive tocilizumab in accordance with the licensed label recommendations, and will be observed for 6 months. The study is designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication is required.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation
时间窗: Month 6
次要结局
- Number of Participants With Different Types of Simplified Disease Activity Index (SDAI)(Baseline up to Month 6)
- Percentage of Participants With Tocilizumab Dose Modifications(Baseline up to Month 6)
- Percentage of Participants With RA Diagnosis(Baseline up to Day 5)
- Percentage of Participants With Rheumatoid Factor Status(Baseline up to Day 5)
- Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria(Baseline up to Month 6)
- Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids(Baseline, up to Month 6)
- Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline(Baseline, Month 1, 2, 3, 4, 5, 6)
- Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6(Baseline, Months 3, 6)
- Percentage of Participants With Different Body Mass Index (BMI)(Baseline up to Day 5)
- Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status(Baseline up to Day 5)
- Number of Participants With Different Types of Clinical Disease Activity Index (CDAI)(Baseline up to Month 6)
- Percentage of Participants Achieving a Response According to ACR Criteria(Month 1, 2, 3, 4, 5, 6)