drugset / Trial / NCT03237260
An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis
Phase 4
Withdrawn
University of Pennsylvania
Corporal Michael J. Crescenz VA Medical Center · collabTakeda · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |