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 Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 499
- 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 in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. 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 current anti-rheumatic therapies, including MTX;
- •inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
- •on stable MTX for at least 8 weeks before entering study;
- •patients of reproductive potential must be using reliable methods of contraception.
排除标准
- •major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study;
- •women who are pregnant or breast-feeding.
研究组 & 干预措施
1
干预措施: Methotrexate (Drug)
1
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
2
干预措施: Methotrexate (Drug)
2
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
3
干预措施: Methotrexate (Drug)
3
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of patients with ACR 20 response
时间窗: Week 24
AEs, laboratory parameters, vital signs, ECGs.
时间窗: Throughout study
次要结局
- Percentage of patients with ACR 50 and ACR 70 responses(Week 24)
- Mean changes in parameters of ACR core set(Week 24)