A Study on Infections in Adults With Ulcerative Colitis/Crohn's Disease

More older people (more than 65 years of age) around the world are getting Ulcerative Colitis (UC) or Crohn's Disease (CD). This is happening because people are living longer and because more people overall are developing UC or CD. Medicines that treat UC/CD, however, might make it easier for older adults to get infections. The main aim of this study is to learn if there is a difference in the number and type of infections in older people when treated with either ENTYVIO or other advance medicines (TNF-alpha inhibitors or ustekinumab) that reduce swelling and pain by blocking a chemical in the body (called TNF-alpha). The study will include people aged 65 years and older UC or CD who used either ENTYVIO with ustekinumab or a TNF-alpha inhibitor between 2016 and 2025. Data will be collected from existing Medicare databases.

NCT Number	NCT07250815
Lead Sponsor	Takeda
Conditions	Ulcerative Colitis, Crohn's Disease
Enrollment	23,900 participants
Start Date	2026-08-15
Primary Completion	2026-12-15 (estimated)
Study Completion	2026-12-15 (estimated)
Updated on ClinicalTrials.gov	2026-07-27