Actively Recruiting
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
Led by Janssen Scientific Affairs, LLC · Updated on 2026-05-08
1056
Participants Needed
1
Research Sites
479 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women with Crohn's disease or ulcerative colitis who are new users of ustekinumab or comparator biologic drugs during the study period
- At least 1 year of enrollment history in the Department of Defense electronic health records immediately before starting ustekinumab or comparator drugs
You will not qualify if you...
- Under 18 years of age on the date of starting treatment
- Not diagnosed with Crohn's disease or ulcerative colitis before or on the start date
- History of HIV diagnosis, organ or tissue transplant, or any cancer (except non-melanoma skin cancer) before or on the start date
- Doctor-diagnosed rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months before or on the start date
- For infection studies, those with the same infection diagnosed within 60 days before and after the start date
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NMCP
Portsmouth, Virginia, United States, 23708
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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