BI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 92
- 主要终点
- Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4
研究概览
简要总结
Primary Objective:
The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD).
Secondary Objectives:
The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 695501
干预措施: BI 695501 (Drug)
HUMIRA + BI 695501
干预措施: BI 695501 (Drug)
HUMIRA + BI 695501
干预措施: HUMIRA (Drug)
结局指标
主要结局
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4
时间窗: Week 4
The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).
次要结局
- Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24(Week 24)
- Percentage of Patients in Clinical Remission (CDAI <150) at Week 24(at Week 24)
- Percentage of Patients With Infections(From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.)
- Percentage of Patients Who Experienced Hypersensitivity Reactions(From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.)
- Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)(From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.)
- Percentage of Patients With Serious Infections(From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.)
- Percentage of Patients With Injection Site Reactions(From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.)
- Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)(From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.)