NCT01834807已完成不适用
Retrospective Study on the Use of Biologicals in Monotherapy in Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Treatment schedule/duration of biological agents used in monotherapy in routine clinical practice
研究概览
简要总结
This retrospective, observational, multi-center study will evaluate the use of biological agents (e.g. RoActemra/Actemra [tocilizumab]) in monotherapy in patients with rheumatoid arthritis. Data from medical record files will be collected of patients currently treated with a biologic in monotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Diagnosis of rheumatoid arthritis
- •Currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted)
排除标准
- •Concomitant treatment with disease-modifying anti-rheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis
- •Patients that have started their current monotherapy before 01/01/2009
结局指标
主要结局
Treatment schedule/duration of biological agents used in monotherapy in routine clinical practice
时间窗: approximately 1 year
Type of biological agents used in monotherapy in routine clinical practice
时间窗: approximately 1 year
次要结局
- Efficacy: Response according to DAS28-ESR/CRP, CDAJ/SDAI, SJC (28) and TJC (28) and other parameters of composite scores(approximately 1 year)
- Safety of biologics used in monotherapy: Incidence of adverse events(approximately 1 year)
- Quality of life: HAQ-DI score(approximately 1 year)
研究者
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