NCT02101307已完成不适用
A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 25
- 主要终点
- Proportion of patients on RoActemra/Actemra treatment 6 months after treatment initiation
研究概览
简要总结
This non-interventional study will observe the usage and efficacy of RoActemra/Actemra in patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment regimen will be directed by the treating physician according to clinical practice. Patients are expected to be observed for approximately 6 months after beginning treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Patients at least 18 years of age
- •Patients with a diagnosis of moderate to severe RA 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). This can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
- •Patient has given informed consent
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 investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- •Patients with a history of autoimmune disease or of any joint inflammatory disease other than RA
结局指标
主要结局
Proportion of patients on RoActemra/Actemra treatment 6 months after treatment initiation
时间窗: 6 months
次要结局
- Proportion of patients with systemic manifestation of RA(At Baseline)
- Efficacy as assessed by total joint count evaluation(6 months)
- Health-related quality of life as assessed by questionnaire(6 months)
- Treatment patterns during observation period, assessed by alteration in dosing regimen(6 months)
- Record of RA treatment history(6 months)
- Incidence of adverse events(6 months)
研究者
研究点 (25)
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