Status:
RECRUITING
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
Lead Sponsor:
Janssen Scientific Affairs, LLC
Conditions:
Crohn Disease
Colitis, Ulcerative
Eligibility:
All Genders
18+ years
Brief Summary
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 biolog...
Eligibility Criteria
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
Exclusion
- 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
Key Trial Info
Start Date :
June 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2030
Estimated Enrollment :
1056 Patients enrolled
Trial Details
Trial ID
NCT04372108
Start Date
June 24 2021
End Date
August 30 2030
Last Update
December 5 2025
Active Locations (1)
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1
NMCP
Portsmouth, Virginia, United States, 23708