NCT00552058已完成3 期
Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 439
- 试验地点
- 116
- 主要终点
- Percentage of Subjects in Clinical Remission at Week 6
研究概览
简要总结
The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male/female
- •18 - 75 years inclusive
- •diagnosis of Crohn's disease confirmed
- •moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
- •no previous treatment with anti-tumor necrosis factor (anti-TNF) medications
排除标准
- •previous participation in a certolizumab pegol study
- •general exclusion criteria as common for studies in this indication
研究组 & 干预措施
Certolizumab pegol
Experimental
Certolizumab pegol 400 mg for subcutaneous (sc) injection
干预措施: certolizumab pegol (CDP870, CZP) (Biological)
Placebo
Placebo Comparator
Placebo, saline solution for sc injection
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Subjects in Clinical Remission at Week 6
时间窗: Week 6
The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
次要结局
- Percentage of Subjects Achieving a Clinical Response at Week 6(Week 0, Week 6)
- Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6(Week 6)
- Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6(Week 0 to Week 6)
- Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6(Week 0 to Week 6)
- Percentage of Subjects in Clinical Remission at Week 2(Week 2)
- Percentage of Subjects in Clinical Remission at Week 4(Week 4)
- Percentage of Subjects Achieving a Clinical Response at Week 2(Week 0, Week 2)
- Percentage of Subjects Achieving a Clinical Response at Week 4(Week 0, Week 4)
- Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2(Week 0 to Week 2)
- Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4(Week 0, Week 4)
- Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2(Week 2)
- Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4(Week 4)
- Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6(Week 6)
- Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6(Week 6)
- Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6(Week 0, Week 6)
- Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6(Week 0, Week 6)
研究者
研究点 (116)
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