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

  • STATUS
    Recruiting
  • End date
    Aug 30, 2030
  • participants needed
    1536
  • sponsor
    Janssen Scientific Affairs, LLC
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Updated on 5 August 2020
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cancer
ustekinumab
crohn's disease
malignancy
biologics
opportunistic infection

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 biologic therapies among adult participants with Crohn's disease (CD).

Details
Condition Inflammatory bowel disease, Inflammatory bowel disease, Crohn's Disease, Crohn's Disease, crohn's disease (pediatric), crohn's disease (pediatric)
Age 18years - 100years
Treatment Ustekinumab, Other Biologic Therapies
Clinical Study IdentifierNCT04372108
SponsorJanssen Scientific Affairs, LLC
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Adult men and women with CD 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 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
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