drugset / Trial / NCT03237260

An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis

NCT03237260

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to determine whether starting the drug vedolizumab earlier than its FDA approved use can lead to better control of UC then using older drugs that we have historically used to treat UC. Vedolizumab is FDA-approved to be used after initial Corticosteroid treatments have failed or other UC treatments have failed. We will study if using vedolizumab as an early treatment for your UC will allow you to get off corticosteroids and prevent UC from worsening and requiring surgery. Vedolizumab is given intravenously initially every 2 weeks and then every 8 weeks.

Timeline

Start
2017-07-01
Primary completion
2019-02-01
Completion
2019-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Vedolizumab Monoclonal antibody 300 mg Intravenous

Indications