A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely 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
- 396
- 试验地点
- 30
- 主要终点
- Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54
研究概览
简要总结
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active 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
- 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
- •Patient is male or female aged 18 to 75 years, inclusive.
- •Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points
排除标准
- •Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives
- •Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.
结局指标
主要结局
Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54
时间窗: Week 54
Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of \<150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54
时间窗: Week 54
Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level.
次要结局
- Percentage of Patients Achieving CDAI-100 Response at Week 54(Week 54)
- Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54(Week 54)
- Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54(Week 54)