NCT00544154已完成3 期
Efficacy and Safety of CDP870 400 mg in Combination With Methotrexate Compared to Methotrexate Alone in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Are Partial Responders to Methotrexate
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
- 247
- 主要终点
- American college of Rheumatolofy (ACR)-20 responder rate at Week 24
研究概览
简要总结
The main purpose of the study was to determine the efficacy of CDP870 in treating RA signs/symptoms in patients who were partial responders to MTX. Other purposes were to show additional efficacy without increased toxicity and the immunogenic response to CDP870 during combined CDP870 and MTX therapy.
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
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 Rheumatolofy (ACR)-20 responder rate at Week 24
次要结局
- health outcomes measures
- immunogenic profile of CDP870 plus methotrexate
- systemic exposure of CDP870
- Safety and tolerability
研究者
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