Last updated on December 2017

A Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes in Non-Responders with Moderately to Severely Active Ulcerative Colitis (ENTERPRET)

Brief description of study

This is a phase 4, open-label, multicenter study to investigate the efficacy and safety of dose optimization of vedolizumab IV, compared with standard dosing of vedolizumab IV, over a 30-week treatment period. This study will enroll adult subjects with moderately to severely active ulcerative colitis (UC) who are eligible for treatment with vedolizumab IV.

There will be up to 12 study visits, across the 30 weeks of treatment, along with a follow-up visit at Week 48, and a long-term follow-up phone call at 6 months from the last study visit.

Patients will receive up to $810 for completing the study, and Takeda has agreed to assist subjects who have finished the trial with obtaining free or lower-cost Entyvio (infusion cost will NOT be included).

Clinical Study Identifier: TX155009

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Gastroenterology Associates of Tidewater

112 Gainsborough Square; Suite 200 Chesapeake, VA USA
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Recruitment Status: Open

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