An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis
Status:
Withdrawn
Trial end date:
2019-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Pennsylvania
Collaborators:
Corporal Michael J. Crescenz VA Medical Center Takeda