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NCT Number: NCT07250815

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda Site

Cambridge, Massachusetts, 02142, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is an observational study, no intervention will be administered.

Primary outcomes

  1. Percentage of Participants Hospitalized Due to Serious Infections

    Time frame: Up to 4 months

    Serious infections will include infections of the respiratory tract, skin and soft tissue, genitourinary tract, gastrointestinal tract, central nervous system, and septicemia/sepsis. The intraabdominal infections, perianal infections, tuberculosis, and other opportunistic infections will not be considered under serious infection requiring hospitalization.

Secondary outcomes

  1. Percentage of Participants with Non-serious Infections

    Time frame: Up to 4 months

    Non-serious infections will include any primary diagnosis of infection that is not associated with hospitalization.

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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