NCT07250815
A Study on Infections in Adults With Ulcerative Colitis/Crohn's Disease
Not Yet Recruiting · Not specified · Takeda · registry updated 2026-08-24
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- UC Study Cohort:
- Participants will be included if they had:
- Greater than or equal to (\>=) 1 medical (for Medicare fee-for-service \[FFS\], Part A/B) or pharmacy claim (for Medicare FFS, Medicare Part D) for an approved AMT for UC during the participant identification period.
- Note: Claim should be on or after the food and drug administration (FDA) treatment-specific approval dates for each drug.
- The date of the first claim during the participant identification period will be designated the Index Date, and the corresponding AMT, the index AMT.
- \>=2 medical (for Medicare FFS, Part A/B) claims, at least 30 days apart, with an ICD-10-CM code for UC during the baseline period or on the Index Date.
Exclusion
- Participants with any of the following will be excluded from the analysis:
- Any evidence of AMT utilization during the Baseline Period.
- Participants with at least 2 ICD-10-CM codes for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, non-infectious uveitis, or psoriatic arthritis during the Baseline Period.
- Participants with 2 or more ICD-10-CM codes for non-dermatologic malignancy during the Baseline Period.