NCT04372108

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,056 (estimated)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Disease
• Colitis, Ulcerative

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-24
• Primary completion: 2029-08-31
• Completion: 2030-08-30
• First posted: 2020-05-01
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States