A Study on Infections in Adults With Ulcerative Colitis/Crohn's Disease
NCT ID: NCT07250815
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
23900 participants
OBSERVATIONAL
2025-12-15
2025-12-15
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Participants with UC
Participants diagnosed with UC who initiated treatment with ENTYVIO or other advanced medical therapies (AMTs) will be identified using a claims-based algorithm. This algorithm incorporates International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes, National Drug Codes (NDC), and Healthcare Common Procedural Coding System (HCPCS) codes to retrospectively assess the safety outcomes data over a period of approximately four months.
No intervention
This is an observational study, no intervention will be administered.
Participants with CD
Participants diagnosed with CD who initiated treatment with ENTYVIO or other AMTs will be identified using a claims-based algorithm. This algorithm incorporates ICD-10-CM codes, NDC, and HCPCS codes to retrospectively assess the safety outcomes data over a period of approximately four months.
No intervention
This is an observational study, no intervention will be administered.
Interventions
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No intervention
This is an observational study, no intervention will be administered.
Eligibility Criteria
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Inclusion Criteria
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
* 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.
65 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Central Contacts
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Related Links
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Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
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EUPAS1000000767
Identifier Type: OTHER
Identifier Source: secondary_id
Vedolizumab-4081
Identifier Type: -
Identifier Source: org_study_id