A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- UCB Pharma
- 入组人数
- 174
- 试验地点
- 68
- 主要终点
- Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38
研究概览
简要总结
The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.
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
- •Men and women
- •Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) score of ≥ 220 ≤450)
排除标准
- •Active or draining fistula present at screening
- •Lactating and/or pregnant female subjects
- •A history of any health condition that could potentially interfere with the disease and/or the treatment
- •A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
- •Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study
- •History of drug or alcohol abuse in the prior year
- •Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0
研究组 & 干预措施
Certolizumab pegol 400 mg
Certolizumab pegol 400 mg
干预措施: certolizumab pegol 400 mg (Biological)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38
时间窗: Week 38
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.
次要结局
- Percentage of Subjects With Continuous Remission Off Steroids at Week 38(Week 38)
- Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period(Over the 38-week double-blind treatment period)
- Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period(6-week run-in period, 38-week double-blind treatment period)
- Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period(During the 38-week double-blind treatment period)
- Change From Baseline in CDAI Score at Week 38(Week 0, Week 38)
- Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38(Week 38)
- Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period(Over the 48-week study period)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38(Week 38)
- Crohn's Disease Activity Index (CDAI) Score at Week 38(Week 38)
- Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38(Week 0, Week 38)