Study examines which IBD drugs are safer for seniors
NCT ID NCT07250815
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 4 times
Summary
This study looked at nearly 24,000 older adults (65+) with ulcerative colitis or Crohn's disease to see if certain advanced treatments lead to more infections. Researchers compared patients taking ENTYVIO, TNF-alpha inhibitors, or ustekinumab using Medicare claims data from 2016 to 2025. The goal was to understand the risk of serious and non-serious infections in this age group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If this study finds differences in infection rates, it could help doctors choose safer treatments for older patients with inflammatory bowel disease.
- What could go wrong
- This is an observational study using existing data, so it cannot prove cause and effect. Results may be influenced by unmeasured factors or differences in patient health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 23,900 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
United States (US) adult participants diagnosed with UC or CD who initiated ENTYVIO or other AMTs will be included in this study.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Takeda Site
Cambridge, Massachusetts, 02142, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a cheap Anti-Inflammatory drug calm ulcerative colitis?
- Lab-Grown gut patches made from Patients' own cells tested against Crohn's ulcers
- Which IBD therapy works best for kids? researchers compare two approaches
- Staph bacteria may hold clues to painful skin rashes in IBD patients on Anti-TNF therapy
- Swallow a camera pill to diagnose Crohn's? trial puts it to the test