NCT01643863终止不适用
A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (TCZ)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 主要终点
- Proportion of patients on RoActemra/Actemra at 6 months
研究概览
简要总结
This multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with 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
- •Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy, in case of methotrexate intolerance or when continuous methotrexate treatment is inadequate (in accordance with the local label), and who have received (or started) RoActemra/Actemra monotherapy treatment within 8 weeks prior to the enrolment visit.
- •Concomitant corticosteroids (oral or intra-articular) or non-steroidal anti-inflammatory drugs (NSAIDs) are allowed
排除标准
- •Patients in whom RoActemra/Actemra is contraindicated according to the approved Summary of Product Characteristics
- •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
- •Concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) when starting treatment with RoActemra/Actemra
- •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
- •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
时间窗: approximately 20 months
次要结局
- Physician Global Assessment of disease activity(approximately 20 months)
- Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment(approximately 20 months)
- Rates of dose modifications/interruptions(approximately 20 months)
- Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs)(approximately 20 months)
- Safety: Incidence of adverse events\n(approximately 20 months)
- Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR(approximately 20 months)
- Patient reported outcomes: Health Assessment Questionnaires(approximately 20 months)
- Time to reduction/withdrawal of corticosteroids(approximately 20 months)
研究者
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