drugset / Trial / NCT02425111
Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.
Timeline
- Start
- 2015-03-30
- Primary completion
- 2017-06-02
- Completion
- 2018-02-21
Publications
- Rimola J, Colombel JF, Bressler B, Adsul S, Siegelman J, Cole PE, Lindner D, Danese S. Magnetic Resonance Enterography Assessment of Transmural Healing with Vedolizumab in Moderate to Severe Crohn's Disease: Feasibility in the VERSIFY Phase 3 Clinical Trial. Clin Exp Gastroenterol. 2024 Jan 27;17:9-23. doi: 10.2147/CEG.S429039. eCollection 2024.
- Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.
- Danese S, Sandborn WJ, Colombel JF, Vermeire S, Glover SC, Rimola J, Siegelman J, Jones S, Bornstein JD, Feagan BG. Endoscopic, Radiologic, and Histologic Healing With Vedolizumab in Patients With Active Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1007-1018.e7. doi: 10.1053/j.gastro.2019.06.038. Epub 2019 Jul 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |