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

Janssen (J&J Innovative Medicine)

Status: Enrolling

Conditions: Colitis, Ulcerative; Crohn Disease

Treatments: Drug: Other Biologic Therapies; Drug: Ustekinumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04372108

CR108561

RRA-18896 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 1,056 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

1,056 participants in 2 patient groups

Ustekinumab New User Cohort

Description:

Participants with crohn's disease (CD) or ulcerative colitis (UC) with no prior exposure to ustekinumab, at least 1 year of enrollment records immediately prior to the new use will be required. The information will be sourced from the Department of Defense (DoD) Electronic Health Records (EHR) database in the United States (US).

Treatment:

Drug: Ustekinumab

Other Biologics Comparator Cohort

Description:

Participants with CD or UC with no prior exposure to the individual drugs (for example, infliximab, adalimumab, or vedolizumab) in question, at least 1 year of enrollment records immediately prior to the new use of the comparator biologic will be required. The information will be sourced from the Department of Defense (DoD) Electronic Health Records (EHR) database in the United States (US).

Treatment:

Drug: Other Biologic Therapies