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NCT07250815 · ClinicalTrials.gov registry record
A Study on Infections in Adults With Ulcerative Colitis/Crohn's Disease
A clinical trial, sponsored by Takeda.
- Not yet
- Registry status
- 23,900
- Enrollment target
NCT07250815: Clinical Trial study, sponsored by Takeda.
NCT07250815 is a clinical trial that has not yet begun recruiting, run by Takeda. The registered enrollment target is 23,900 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07250815 has not yet begun recruiting, sponsored by Takeda.
- NOT YET RECRUITING
- Registry status
- 23,900 participants
- Enrollment target
Study 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.
Primary Outcome
Serious infections will include infections of the respiratory tract, skin and soft tissue, genitourinary tract, gastrointestinal tract, central nervous system, and septicemia/sepsis. The intraabdominal infections, perianal infections, tuberculosis, and other opportunistic infections will not be considered under serious infection requiring hospitalization.
Interventions
- OTHER No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23,900 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2026-12-15 |
What is known before NCT07250815 opens enrollment
NCT07250815 is an observational study that tracks outcomes without assigning an intervention. Its 23,900 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.
NCT07250815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07250815 about?
NCT07250815 is a clinical study titled "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 ...
What is the current status of trial NCT07250815?
This trial is currently not yet recruiting. The enrollment target is 23,900 participants. The study started on 2026-07-15. Estimated completion is 2026-12-15.
What interventions are being tested in trial NCT07250815?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT07250815?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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