NCT01337388已完成不适用
An Observational Study of the Efficacy of RoActemra in Smoking vs Non-smoking Patients With Rheumatoid Arthritis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197
- 主要终点
- Change in disease activity score (DAS 28)
研究概览
简要总结
This observational study will assess the efficacy and safety of RoActemra/Actemra (Tocilizumab) in smoking versus non-smoking patients with rheumatoid arthritis. Data from patients treated in routine clinical practice with intravenous RoActemra/Actemra will be collected for 12 months each.
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
- •Rheumatoid arthritis, defined as fulfilling at least 4 of 7 American College of Rheumatology (ACR) criteria
- •Treatment with RoActemra/Actemra
排除标准
- •Participation in interventional clinical studies
结局指标
主要结局
Change in disease activity score (DAS 28)
时间窗: 12 months
Treatment patterns (frequency/dosage) and demographics of patients treated with RoActemra/Actemra in routine clinical practice
时间窗: 36 months
次要结局
- Safety: Incidence of adverse events(36 months)
- Clinical response (DAS 28/blood chemistry/QoL) with or without methotrexate(36 months)
- Quality of life: Health assessment questionnaire Disease Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) questionnaire(12 months)
- Rate of patients achieving remission (DAS <2.6)(36 months)
- Change in blood lipids(12 months)
研究者
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