NCT00106574已完成3 期
A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
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
- 1,220
- 主要终点
- Percentage of patients with ACR 20 response
研究概览
简要总结
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. 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
- •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 1 or more traditional DMARDs;
- •stable DMARD therapy 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 entering study, or planned surgery within 6 months after entering study;
- •patients who have previously failed treatment with an anti-tumor necrosis factor agent;
- •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
Placebo Comparator
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
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)
- AEs, laboratory parameters, vital signs.(Throughout study)
研究者
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