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RECRUITING
NCT04372108

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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