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 19 February 2024

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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	18-100 years
Treatment	Ustekinumab, Other Biologic Therapies
Clinical Study Identifier	NCT04372108
Sponsor	Janssen Scientific Affairs, LLC
Last Modified on	19 February 2024

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