A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in

TAKEDA DEVELOPMENT CENTRE EUROPE LTD0 个研究点目标入组 771 人开始时间: 2021年6月8日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•The subject has a diagnosis of UC established at least 6 months prior to enrollment, by clinical and endoscopic evidence and corroborated by a histopathology report.
•The subject has moderately to severely active UC as determined by a complete Mayo score of 6-12 with an endoscopic subscore =2 within 14 days prior to randomization.
•The subject has evidence of UC extending proximal to the rectum (=15 cm of involved colon).
•The subject has had previous treatment with tumor necrosis factor–alpha (TNF-a) antagonists without documented clinical response to treatment or the subject is naïve to TNF-a antagonist therapy but is failing current conventional treatment.
•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 638
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•The subject has had extensive colonic resection, subtotal or total colectomy.
•The subject has any evidence of an active infection during Screening.
•The subject has a positive progressive multifocal leukoencephalopathy (PML) subjective checklist before the administration of study drug.
•The subject has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to screening (whichever is longer).
•The subject has had prior exposure to vedolizumab, natalizumab, efalizumab, adalimumab or rituximab.

发起方