A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
Last Updated February 22, 2025
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CR108561
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 11 -
Sites
Sites -
Status
Recruiting
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).
CONDITIONS
- Crohn's Disease
- Colitis, Ulcerative
ELIGIBILITY
Inclusion Criteria:
* Adult men and women with CD or UC who are new users of ustekinumab or the comparator drugs during the study period
* Participants must have at least 1 year of enrollment history with the DoD EHR database immediately prior to new use (that is, exposure index
DETAILS
LOCATIONS
Country (1) | City or Province (1) | Status |
United States | Portsmouth NMCP |
RECRUITING
|
36.83543, -76.29827
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