NCT00291668已完成2 期
A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 94
- 试验地点
- 22
- 主要终点
- Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6
研究概览
简要总结
This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting date of the observation period
- •Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period
- •C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period
排除标准
- •Stoma patient
- •Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
- •Patients who participated in a clinical study with CDP870
- •Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
- •Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators
- •Exclusion Criteria:
研究组 & 干预措施
Certolizumab pegol 200 mg
Experimental
Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
干预措施: Placebo (Other)
Placebo
Placebo Comparator
Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
干预措施: Placebo (Other)
Certolizumab pegol 400 mg
Experimental
Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
干预措施: Certolizumab Pegol (Biological)
Certolizumab pegol 200 mg
Experimental
Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
干预措施: Certolizumab Pegol (Biological)
结局指标
主要结局
Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6
时间窗: Baseline, Week 6
CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0). Remission is defined as a CDAI of \<= 150 at Week 6.
次要结局
- C-reactive Protein (CRP) Ratio to Baseline at Week 2(Baseline, Week 2)
- Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2(Week 2)
- Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2(Baseline, Week 2)
- Concentration of C-reactive Protein (CRP) Value at Week 2(Week 2)
- Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6(Baseline, Week 6)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2(Week 2)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2(Week 2)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6(Week 6)
- Crohn's Disease Activity Index (CDAI) Score at Week 2(Week 2)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4(Week 4)
- C-reactive Protein (CRP) Ratio to Baseline at Week 4(Baseline, Week 4)
- Concentration of C-reactive Protein (CRP) Value at Week 4(Week 4)
- Crohn's Disease Activity Index (CDAI) Score at Week 4(Week 4)
- Crohn's Disease Activity Index (CDAI) Score at Week 6(Week 6)
- Percentage of Subjects Who Achieve CDAI Response at Week 2(Baseline, Week 2)
- Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2(Baseline, Week 2)
- Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4(Baseline, Week 4)
- Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4(Week 4)
- Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4(Baseline, Week 4)
- Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6(Baseline, Week 6)
- Concentration of C-reactive Protein (CRP) Value at Week 6(Week 6)
- Percentage of Subjects Who Achieve CDAI Response at Week 4(Baseline, Week 4)
- Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6(Week 6)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6(Week 6)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4(Week 4)
- C-reactive Protein (CRP) Ratio to Baseline at Week 6(Baseline, Week 6)
研究者
研究点 (22)
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