Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 771

Inclusion Criteria

1.Has a diagnosis of ulcerative colitis established at least 3 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
2.Has moderately to severely active ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days prior to the randomization.
3.Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of involved colon).
4.a.Has had previous treatment with tumor necrosis factor–alpha (TNF-a) 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-a antagonist (except adalimumab), and discontinued its use due to reasons other than safety
5. Is naïve to TNF-a antagonist therapy but is failing current treatment (ie, corticosteroids, 5-aminosalicylate, or immunomodulators)..

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 735
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

1.The subject has had an extensive colonic resection, subtotal or total colectomy.
2.The subject has any evidence of an active infection during Screening.
3.The subject has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist at Screening or before the administration of study drug at Day 1.
4. 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).
5. 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of vedolizumab IV compared to adalimumab SC on clinical remission at Week 52.;<br> Secondary Objective: • To evaluate the effect of vedolizumab IV compared to adalimumab SC on mucosal healing at Week 52.<br> • To evaluate the effect of vedolizumab IV compared to adalimumab SC on corticosteroid-free remission at Week 52.<br> ;Primary end point(s): Proportion of subjects achieving clinical remission (defined as a complete Mayo score of =2 points and no individual subscore >1 point) at Week 52.;Timepoint(s) of evaluation of this end point: Week 52

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): • Proportion of subjects achieving mucosal healing (defined as Mayo endoscopic subscore =1 point) at Week 52.<br> • Proportion of subjects using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission at Week 52.<br> ;Timepoint(s) of evaluation of this end point: Week 52

Updated 4/30/2019

Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC

Recruitment & Eligibility

Study & Design

Related Trials