clinical trial · NCT04372108
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
Janssen Scientific Affairs, LLC·—·recruiting·n = 1,056
Crohn DiseaseColitis, UlcerativeUstekinumabOther Biologic Therapies
brief 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).
started
Jun 24, 2021
primary completion
Aug 31, 2029
completion
Aug 30, 2030
last updated
Apr 13, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol