ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Older adults with IBD may face different infection risks when treated with advanced biologic therapies. This study aims to compare hospitalizations for serious infections after starting vedolizumab (ENTYVIO) versus TNF inhibitors or ustekinumab using Medicare data, which could inform treatment decisions for people 65+.
Who Should Pay Attention
Older adults (65+) with UC or Crohn’s disease; caregivers; clinicians prescribing biologics/advanced therapies; researchers studying biologic safety in real-world older populations.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment23,900 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This is a ClinicalTrials.gov record for an observational study (not yet recruiting) sponsored by Takeda that will use Medicare claims data to compare infections in people aged 65+ with ulcerative colitis or Crohn’s disease who started treatment with ENTYVIO (vedolizumab) versus other advanced therapies (TNF inhibitors or ustekinumab) between 2016–2025.
The main outcome is percentage hospitalized for serious infections within about four months after treatment start; the study will use claims-based algorithms (ICD-10, NDC, HCPCS) and will not administer any interventions.
The record describes planned inclusion/exclusion rules, the intended data sources (Medicare claims), cohorts for UC and CD, and that some infections (e.g., intraabdominal, perianal, TB, opportunistic infections) are excluded from the defined “serious infections requiring hospitalization.”
Keep In Mind
This is a planned, observational study using retrospective Medicare claims (not a randomized trial). It is not yet recruiting and the registry entry describes planned methods and outcomes but reports no results.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorTakeda
Trial IDNCT07250815
Study typeObservational
Enrollment23,900 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedJul 27, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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