NCT07250815

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

Infection Outcomes Among Advanced Therapy-naive Older Adult US Patients With UC/CD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23,900 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ulcerative Colitis
• Crohn's Disease

Interventions

Type	Name	Description
OTHER	No intervention	This is an observational study, no intervention will be administered.

Timeline

• Start date: 2025-12-15
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2025-11-26
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States