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A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
Sponsor: Janssen Scientific Affairs, LLC
Summary
The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).
Official title: An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1056
Start Date
2021-06-24
Completion Date
2030-08-30
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Ustekinumab
Participants who are new users of ustekunumab will be included in the cohort. No study treatment will be administered as a part of this study.
Other Biologic Therapies
Participants who are new users of other biologic therapies (for examples for example, infliximab, adalimumab, or vedolizumab administered as per the prescription record) will be included in this cohort. No study treatment will be administered as a part of this study.
Locations (1)
NMCP
Portsmouth, Virginia, United States