NCT01388309已完成不适用
DAS Evaluation of RA Activity in 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
- 64
- 主要终点
- Disease activity score (DAS28)
研究概览
简要总结
This observational study will evaluate in clinical practice the change in Disease Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 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 active rheumatoid arthritis
- •Inadequate response or intolerance to previous therapy with one or more traditional DMARDs
排除标准
- •Pregnant or lactating women
- •Active infection
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Concomitant anti-TNF drugs
- •Contraindications to treatment with RoActemra/Actemra
结局指标
主要结局
Disease activity score (DAS28)
时间窗: 12 months
次要结局
- DAS 28 (subgroup on monotherapy)(12 months)
- Safety: Incidence of adverse events(12 months)
- DAS 28 (subgroup on 4 mg/kg dose)(12 months)
研究者
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