A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 623
- 主要终点
- Percentage of patients with ACR 20 response
研究概览
简要总结
This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. 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 moderate to severe active RA for at least 6 months;
- •inadequate response to a stable dose of MTX;
- •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 surgery within 6 months after entering study;
- •prior treatment failure with an anti-tumor necrosis factor agent;
- •women who are pregnant or breast-feeding.
研究组 & 干预措施
1
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
1
干预措施: Methotrexate (Drug)
2
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
2
干预措施: Methotrexate (Drug)
3
干预措施: Placebo (Drug)
3
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
- Percentage of patients ACR 50/70 responses; change from baseline in ACR core set components.(Week 24)
- AEs, laboratory parameters, vital signs(Throughout study)