NCT01384461已完成不适用
An Open-label, Multicenter Non-interventional Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in 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
- 251
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This observational study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate (weekly dose at the discretion of the physician).
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
- •RoActemra/Actemra treatment initiated by rheumatologist in an Arthritis Center for (up to 2 months prior to study entry)
排除标准
- •History of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug
- •Active, severe infection or history of recurrent clinically significant infection
- •Pregnancy
- •Treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit
- •Methotrexate intolerance
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: 12 months
次要结局
- Pain: Visual Analogue Scale (VAS) pain scale(12 months)
- Physical Function: Health Assessments Questionnaire (HAQ)(12 months)
- Efficacy: Disease Activity Score (DAS 28)(12 months)
- Incidence of patients with all-cause discontinuation of tocilizumab(12 months)
研究者
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