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

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Takeda
Study ID
NCT07250815
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • No intervention — OTHER
    This is an observational study, no intervention will be administered.

Study Details

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.

Key Dates

Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
23,900 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Percentage of Participants Hospitalized Due to Serious Infections [ Time Frame: Up to 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Takeda SiteCambridgeMassachusetts02142-

Find similar trials in Cambridge, MA

By condition
Crohn's diseaseUlcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Takeda Site· Cambridge, MA

Related Studies