Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease

Summary

The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.

Timeline

Start

2016-08-01

Primary completion

2023-01-03

Completion

2023-01-03

Publications

• Danese S, Lukas M, Volfova M, Rydzewska G, Adsul S, Lindner D, Jones S, Vermeire S. Final results from the vedolizumab extended access program multinational study demonstrate long-term treatment persistence and safety. Ther Adv Gastroenterol. 2026 Feb 9;19:17562848251406092. doi: 10.1177/17562848251406092. eCollection 2026.
• Danese S, Subramaniam K, Van Zyl J, Adsul S, Lindner D, Roth J, Vermeire S. Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme. Aliment Pharmacol Ther. 2021 Jan;53(2):265-272. doi: 10.1111/apt.16160. Epub 2020 Nov 18.

Drugs

Indications