Last updated on November 2017

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy


Brief description of study

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Detailed Study Description

The purpose of the study is to assess the effect of Vedolizumab subcutaneously on clinical remission at Week 52 in subjects with moderately to severely active UC, who achieved a clinical response at Week 6, following the administration of Vedolizumab IV.

Clinical Study Identifier: TX5538

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Crystal Beaber, MA, CCRC

Gastroenterology Associates of Tidewater
Chesapeake, VA USA
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