BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, non-inferiority trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.

Boehringer Ingelheim International GmbH0 个研究点目标入组 286 人开始时间: 2017年2月2日最近更新: 2019年12月16日

适应症

试验速览

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•1. Males and females aged =18 and =80 years who have a diagnosis of moderate to severely active CD, confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following:
•a. CDAI score of =220 and =450
•b. A diagnosis of CD confirmed by ileocolonoscopy during Screening
•c. Endoscopic documentation of ulceration at Screening corresponding to a score of 2 or 3 in at least one of the five segments of the colon on the Ulcerated Surface subscore of the SES-CD
•2. Anti-TNF naïve patients or previously treated with infliximab or any other anti TNF agent (except adalimumab) who had initially responded and who meet one of the following criteria:
•a. Responded and developed secondary resistance due confirmed anti-infliximab ADA formation, which caused infliximab depletion
•b. Responded and became intolerant
•3. Willing to undergo up to 3 endoscopies
•4. For participants of reproductive potential, a reliable means of contraception has to be used throughout trial participation.
•5. Signed and dated written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 271
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1. Ulcerative colitis or indeterminate colitis
•2. Symptomatic known obstructive strictures
•3. Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while in the trial
•4. Ostomy or ileoanal pouch
•5. Short bowel syndrome

发起方