NCT00109408已完成3 期
A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 673
- 主要终点
- Percentage of patients with ACR 20 response
研究概览
简要总结
This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 at least 18 years of age with active RA for at least 3 months;
- •patients of reproductive potential must be using reliable methods of contraception.
排除标准
- •major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
- •treatment with methotrexate (MTX) within 6 months of entering study;
- •patients who have stopped previous MTX treatment due to toxicity or lack of response;
- •women who are pregnant or breast-feeding.
研究组 & 干预措施
1
Experimental
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
2
Active Comparator
干预措施: Methotrexate (Drug)
结局指标
主要结局
Percentage of patients with ACR 20 response
时间窗: Week 24
次要结局
- Mean change in parameters of ACR core set(Week 24)
- AEs, laboratory parameters, vital signs.(Throughout study)
- Percentage of patients with ACR 50 and ACR 70 responses(Week 24)
- Percentage of patients with ACR 20 response(Week 8)
研究者
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