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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
Ustekinumab New User Cohort 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).
  • 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.
Other Biologics Comparator Cohort 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).
  • 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.

Recruiting Locations

BAMC
Houston, Texas 78234

More Details

Status
Recruiting
Sponsor
Janssen Scientific Affairs, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com