Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

Summary

The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).

Timeline

Start

2016-08-10

Primary completion

2018-09-04

Completion

2018-11-14

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Enrollment was stopped prematurely because of recruitment challenges; analyses are descriptive. PMID 34597729 ↗

Publications

• Schwartz DA, Peyrin-Biroulet L, Lasch K, Adsul S, Danese S. Efficacy and Safety of 2 Vedolizumab Intravenous Regimens for Perianal Fistulizing Crohn's Disease: ENTERPRISE Study. Clin Gastroenterol Hepatol. 2022 May;20(5):1059-1067.e9. doi: 10.1016/j.cgh.2021.09.028. Epub 2021 Sep 29.

Drugs

Indications