An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 106
- 试验地点
- 63
- 主要终点
- Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)
研究概览
简要总结
This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 previously enrolled in C87059 (COSPAR I, NCT00349752)
排除标准
- •Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions
- •Subject who received treatment other than study medication and other than medications permitted in C87059 (COSPAR I, NCT00349752)
- •Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
研究组 & 干预措施
CDP870 400 mg
Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
干预措施: Certolizumab pegol (Biological)
结局指标
主要结局
Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)
时间窗: During this study (maximum 122 weeks)
Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.
次要结局
- Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.(Week 34 in this study)