drugset / Trial / NCT04797325
Vedolizumab for Immune Mediated Colitis
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open label randomized trial to evaluate the efficacy and treatment duration with vedolizumab to patients with immune mediated colitis. The trial will include 82 patients randomized into two arms, either standard treatment with prednisolone (plus infliximab in severe cases) or vedolizumab treatment up front.
Timeline
- Start
- 2021-08-30
- Primary completion
- 2025-04
- Completion
- 2025-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prednisolone | Other / unclassified | — | — |
| Comparator | Vedolizumab | Monoclonal antibody | — | — |
| Background | Infliximab | Monoclonal antibody | — | — |
Indications
No indication recorded.