A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6
研究概览
简要总结
This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points
排除标准
- •Patient who has previously received a biological agent for the treatment of Crohn's disease and/or a Tumor necrosis factor (TNF)-alpha inhibitor for the treatment of other disease.
- •Patient who has allergies to any of the excipients of infliximab, any other murine and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.
研究组 & 干预措施
CT-P13 - Remicade
CT-P13 followed by Remicade from Week 30
干预措施: CT-P13 (Biological)
Remicade - CT-P13
Remicade followed by CT-P13 from Week 30
干预措施: CT-P13 (Biological)
CT-P13 - CT-P13
CT-P13 followed by CT-P13 from Week 30
干预措施: CT-P13 (Biological)
CT-P13 - Remicade
CT-P13 followed by Remicade from Week 30
干预措施: Remicade (Biological)
Remicade - CT-P13
Remicade followed by CT-P13 from Week 30
干预措施: Remicade (Biological)
Remicade - Remicade
Remicade followed by Remicade from Week 30
干预措施: Remicade (Biological)
结局指标
主要结局
The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6
时间窗: at Week 6
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.
次要结局
- The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54(Week 54)
- The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)(Up to Week 30)
- The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30(Week 30)
- The Number and Percentage of Patients Achieving Clinical Remission at Week 6(Week 6)
- The Number and Percentage of Patients Achieving Clinical Remission at Week 54(Week 54)
- The Number and Percentage of Patients Achieving Clinical Remission at Week 30(Week 30)
- The Short Inflammatory Bowel Disease Questionnaire(Baseline and Week 54)