NCT01952509已完成不适用
Multinational, Multicenter, Non Interventional Study, in Patients With Rheumatoid Arthritis (RA) Treated With Tocilizumab.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 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 multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the local 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
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 any 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: approximately 2 years
次要结局
- Rates of dose modifications/interruptions(approximately 2 years)
- Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment(approximately 2 years)
- Proportion of patients on RoActemra/Actemra monotherapy at study entry and at Month 6(approximately 2 years)
- Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR(approximately 2 years)
- Safety: Incidence of adverse events(approximately 2 years)
- Health Assessment Questionnaire Disability Index(approximately 2 years)
- Visual Analogue Scale - Fatigue(approximately 2 years)
- Visual Analogue Scale - severity of pain(approximately 2 years)
- Visual Analogue Scale - morning stiffness(aproximately 2 years)
- Patient Global Assessment of disease activity(approximately 2 years)
研究者
相似试验
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
撤回
不适用
A Non-Interventional Study in Patients With Rheumatoid Arthritis Who Are Treated With RoActemra/Actemra (Tocilizumab)Rheumatoid ArthritisNCT01893255Hoffmann-La Roche
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
An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)Rheumatoid ArthritisNCT01483326Hoffmann-La Roche215
已完成
不适用
An Observational Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (ACTIVATE)Rheumatoid ArthritisNCT01384461Hoffmann-La Roche251