Clinical Trial

A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis

Recruiting
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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).
Protocol Amendment History 1 change
notable Enrollment increased: 1056 -> 1536 participants 2026-08-01
Trial Details
NCT Number NCT04372108
Lead Sponsor Janssen Scientific Affairs, LLC
Conditions Crohn Disease, Colitis, Ulcerative
Enrollment 1,536 participants
Start Date 2021-06-24
Primary Completion 2029-08-31 (estimated)
Study Completion 2030-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-31