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
- Conditions
- inflammatory bowel diseaseulcerative colitis10017969
- Registration Number
- NL-OMON43558
- Lead Sponsor
- Takeda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
* The subject has a diagnosis of UC established at least 3 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).;* a. The subject has had previous treatment with tumor necrosis factor*alpha (TNF-*) antagonists without documented clinical response to treatment (eg, due to lack of response [primary nonresponders], loss of response, or intolerance [secondary nonresponder], or
b. Has previously used a TNF-alpha antagonist (except adalimumab), and discontinued its use due to reasons other than safety.;* The subject is naïve to TNF-alpha antagonist therapy but is failing current treatment (ie, corticosteroids, 5-aminosalicylate, or immunomodulators).
* 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 symptom checklist at Screening or before the administration of study drug at Day 1. ;* The subject has received any investigational or approved biologic or biosimilar agent (other than those listed below) within 60 days or 5 half lives prior to screening (whichever is longer).;* The subject has had prior exposure to vedolizumab, natalizumab, efalizumab, adalimumab, etrolizumab, AMG-181, anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1)-antibodies or rituximab.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for the study is proportion of subjects achieving clinical<br /><br>remission (defined as a complete Mayo score of *2 points and no individual<br /><br>subscore >1 point) at Week 52.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints for this study are:<br /><br><br /><br>* Proportion of subjects achieving mucosal healing (defined as Mayo endoscopic<br /><br>subscore *1 point) at Week 52.<br /><br>* Proportion of subjects using oral corticosteroids at Baseline who have<br /><br>discontinued corticosteroids and are in clinical remission at Week 52.</p><br>