NCT01893255撤回不适用
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
- 撤回
- 主要终点
- Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation
研究概览
简要总结
This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved 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
- •Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label; this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
- •Patients who for any reason do not take methotrexate and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
- •Patients who were previously on a TNF inhibitor as monotherapy, and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
- •Concomitant treatment with corticosteroids (orally and intra-articularly) and/or NSAIDs is allowed
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 receiving concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
- •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
结局指标
主要结局
Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation
时间窗: Month 6
次要结局
- Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment(approximately 6 months)
- Rates of dose modifications/interruptions(approximately 6 months)
- Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR(approximately 6 months)
- Physician's Global Assessment of Disease Activity(approximately 6 months)
- Safety: Incidence of adverse events(approximately 6 months)
- Patient reported outcomes (Patient Global Assessment of disease activity, HAQ-DI, VAS-Fatigue, severity of pain and morning stiffness)(approximately 6 months)
研究者
相似试验
已完成
不适用
A Non-Interventional Study in Patients With Moderate to Severe Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)Rheumatoid ArthritisNCT01663506Hoffmann-La Roche23
已完成
不适用
A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in MonotherapyRheumatoid ArthritisNCT01705730Hoffmann-La Roche71
已完成
不适用
A Non-Interventional Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisNCT01672970Hoffmann-La Roche291
已完成
不适用
A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) Treatment in Patients With Rheumatoid ArthritisRheumatoid ArthritisNCT01952509Hoffmann-La Roche169
已完成
不适用
A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisNCT01670045Hoffmann-La Roche43