Long-term Treatment Study of CDP870 Self-injection. A Multicenter, Open-label, Long-term Safety Study to Evaluate the Safety and Efficacy of CDP870 Self-injection Administered at a Dose of 200 mg Biweekly for 24 Weeks or Longer in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870 Administered Concomitantly With or Without Methotrexate (MTX)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Percentage of subjects experiencing at least one adverse event or at least one serious adverse event during the study
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of CDP870 self-injection administered for 24 weeks or longer in subjects who are participating in the long-term treatment study (Study 275-08-002 or Study 275-08-004) of CDP870 administered concomitantly with or without Methotrexate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed the treatment in the parent clinical studies (NCT00851318 and NCT00850343) up to 52 weeks
- •Subjects who are willing to undertake self-injection and provide a written consent
排除标准
- •Patients with serious adverse events
- •Patients who are judged by the investigator/subinvestigator to be ineligible to participation in the study for reasons such as uncooperative attitude or nonadherence to study procedures.
研究组 & 干预措施
CDP870 group from Study 275-08-002
Subjects with active rheumatoid arthritis who are participating in Study 275-08-002 of CDP870
干预措施: CDP870 (Drug)
CDP870 group from Study 275-08-004
Subjects with active rheumatoid arthritis who are participating in Study275-08-004 of CDP870
干预措施: CDP870 (Drug)
结局指标
主要结局
Percentage of subjects experiencing at least one adverse event or at least one serious adverse event during the study
时间窗: The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 116 weeks.
Percentage of subjects who meet the American College of Rheumatology 20% (ACR20) criteria at Week 12
时间窗: at Week 12
Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 24
时间窗: at Week 24
Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 24
时间窗: at Week 24
Percentage of subjects who meet ACR20 criteria at Week 24
时间窗: at Week 24
Percentage of subjects who meet the American College of Rheumatology 70% (ACR70) criteria at Week 12
时间窗: at Week 12
Percentage of subjects who meet the American College of Rheumatology 50% (ACR50) criteria at Week 12
时间窗: at Week 12
次要结局
未报告次要终点