NCT00307931终止3 期
Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- UCB Pharma
- 入组人数
- 16
- 试验地点
- 5
- 主要终点
- Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6
研究概览
简要总结
An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to infliximab but who no longer have a sustained response or became intolerant to infliximab
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Adult men and women with Crohn's disease previously responsive to infliximab who became non-responsive or intolerant
排除标准
- •Symptomatic obstructive intestinal strictures
- •Bowel resection within 4 weeks
- •Current total parenteral nutrition
- •Short bowel syndrome
- •Concomitant disease or pathological condition that could interfere with Crohn's disease or to be harmful for the well being of the patient.
结局指标
主要结局
Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6
时间窗: Baseline, Week 6
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
次要结局
- Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal(Baseline to Weeks 1, and 14 or Withdrawal)
- Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14(Baseline to Weeks 1, 6 and 14)
- Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal(Weeks 1, 6 and 14 or Withdrawal)
- Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14(Weeks 1, 2, 4, 6, 8, 12 and 14)
- Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14(Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14)
- C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14(Weeks 1, 2, 4, 6, 8, 12 and 14)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14(Baseline, and Weeks 6 and 14)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14(Baseline, and Weeks 6 and 14)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14(Baseline, and Weeks 6 and 14)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14(Baseline, and Weeks 6 and 14)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14(Baseline, and Weeks 6 and 14)
研究者
研究点 (5)
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