NCT07250815Withdrawn
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Study type
- Observational
- Enrollment
- 0 (actual)
- First submitted
- 18 Nov 2025
- Start date
- 21 Sept 2026
- Primary completion date
- 15 Dec 2026
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07250815
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants with 2 or more ICD-10-CM codes for non-dermatologic malignancy during the Baseline Period.
Other
- 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.
Who the study is looking for
- 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.
- Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.
- CD Study Cohort:
- Participants will be included if they had:
- >=1 medical (for Medicare FFS, Part A/B) or pharmacy claim (for Medicare FFS, Part D) for an approved AMT for CD during the Participant Identification Period.
- Note: Claim should be on or after the FDA treatment-specific approval dates for each drug.
- The date of the first claim during the Patient 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 CD during the Baseline Period or on the Index Date.
- Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.
- If a participant has both a UC and CD diagnosis during the baseline period or on the index date, the diagnosis most proximate to or on the index date will be used to categorize the participant as having UC or CD.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Cambridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.