RecruitingNCT04372108

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

Sponsor

Janssen Scientific Affairs, LLC

Enrollment

1,056 participants

Start Date

Jun 24, 2021

Study Type

OBSERVATIONAL

Conditions

Crohn Disease Colitis Ulcerative

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 date) of ustekinumab or the comparator drugs

Exclusion Criteria5

Participants below 18 years of age on the exposure index date
Participants who do not meet the definition for CD or UC prior to or on the exposure index date
Participants with any records of human immunodeficiency virus (HIV) diagnosis, organ or tissue transplant, or malignancy (excluding non-melanoma skin cancer \[NMSC\]) at any time prior to or on the exposure index date
Participants with a physician diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months prior to or on the exposure index date
In the analysis of infection outcomes, participants diagnosed with the same infection of interest both within 60 days prior to or on the exposure index date and within 60 days after the exposure index date will be excluded

Interventions

DRUGUstekinumab

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.

DRUGOther 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.