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

StatusWithdrawn
PhaseNot specified
SponsorTakeda
Started

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Record History

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  1. Withdrawn before enrolling Sponsor's reason: Sponsor decision
    • Enrollment target: estimated 23900 to confirmed 0
    • Eligibility criteria expanded, about 7 words
  2. Start date: Aug 15, 2026 to Sep 21, 2026v6
  3. Start date: Jul 15, 2026 to Aug 15, 2026v5
  4. Primary and study completion dates: Dec 15, 2025 to Dec 15, 2026
    • Start date: Dec 15, 2025 to Jul 15, 2026
    • Trial status: Completed to Not Yet Recruiting
    v4
  5. Trial status: Not Yet Recruiting to Completed
    • Study sites: 0 to 1
    v3
  6. Primary and study completion dates: Dec 1, 2025 to Dec 15, 2025
    • Start date: Dec 1, 2025 to Dec 15, 2025
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Takeda
222 trials monitored
See 14 trials at risk
Crohn's Disease
643 trials monitored
See 36 trials at risk
Ulcerative Colitis
627 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT07250815
Lead Sponsor Takeda
Conditions
(from sponsor)		 Ulcerative Colitis, Crohn's Disease
Related terms Colitis, Ulcerative, Crohn Disease
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov