Compares long-term safety of ustekinumab with other biologics in Crohn's and colitis
Compares side effects of ustekinumab and other biologics in adults with Crohn's or colitis.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
Key facts
- Where
- Houston, United StatesSee the site
Where in United States
- BAMCHouston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Scientific Affairs, LLC
- Trial code
- NCT04372108
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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. Gaps in enrollment of ≤30 days will be considered continuous enrollment.
Exclusion: 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; Participants below 18 years of age on the exposure index date.