Actively Recruiting
An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety of ustekinumab compared to other biologic therapies in adults with Crohn's disease or ulcerative colitis. The study aims to estimate and compare the rates of overall malignancy, serious infections, and opportunistic infections among new users of these treatments. This observational study uses electronic health records from the Department of Defense in the United States to gather data. The study includes two groups: participants who are new users of ustekinumab and those who are new users of other biologic drugs such as infliximab, adalimumab, or vedolizumab. No treatments are administered as part of the study; instead, it observes participants' health outcomes based on their prescribed therapies. Participants must have at least one year of prior enrollment records before starting the biologic therapy to be included. Participants' health information will be monitored through electronic health records for up to 10 years and 3 months. Researchers will track the rates of malignancies, serious infections, and opportunistic infections during this time. The study does not involve additional treatments or procedures, focusing instead on long-term safety outcomes using existing medical records.
CONDITIONS
Brief 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 drugs during the study period
- At least 1 year of enrollment history with the Department of Defense electronic health records immediately before starting ustekinumab or comparator drugs
You will not qualify if you...
- Participants under 18 years old at the time of starting the biologic therapy
- Participants without a confirmed diagnosis of Crohn's disease or ulcerative colitis before or on the start date of therapy
- History of HIV infection, organ or tissue transplant, or any malignancy except non-melanoma skin cancer before or on the start date
- Diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months before or on the start date
- Participants with the same infection diagnosed both within 60 days before and after starting therapy when analyzing infection outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 10 years and 3 months
Participants who are new users of ustekinumab or other biologic therapies are observed for long-term safety outcomes without receiving any study treatment.
Periodic assessments using health records over the study duration
Trial Site Locations
Total: 1 location
1
NMCP
Portsmouth, Virginia, United States, 23708
Actively Recruiting
Research Team
S
Study 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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here