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

NCT04372108 · Janssen Scientific Affairs, LLC
In plain English

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Official title
RRA-18896: An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database
About this study
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).
Eligibility criteria
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
Enrollment target: 1056 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-06-24
Estimated completion: 2030-08-30
Last updated: 2026-07-07
Interventions
Drug: UstekinumabDrug: Other Biologic Therapies
Primary outcomes
  • Incidence Rate for Malignancy (Up to 10 years and 3 months)
Sponsor
Janssen Scientific Affairs, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Scientific Affairs, LLC Clinical Trial · study_director, Janssen Scientific Affairs, LLC
All locations (1)
BAMCRecruiting
Houston, Texas, United States
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis · TrialPath