NCT00548834已完成3 期
Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 220
- 主要终点
- American College of Rheumatology (ACR)-20 responder rate at Week 24
研究概览
简要总结
The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male/female, 18-75 years old, inclusive
- •diagnosis of adult-onset RA
- •had active disease
- •had received methotrexate
- •on a stable dose of folic acid
排除标准
- •contraindication for methotrexate or anti-TNF
结局指标
主要结局
American College of Rheumatology (ACR)-20 responder rate at Week 24
时间窗: 24 weeks
次要结局
- safety and tolerability every 4 weeks(Every 4 weeks)
- effect of CDP870 on health outcomes measures(24 weeks)
- systemic exposures and immunogenic profile of CDP870(24 weeks)
研究者
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