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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen Scientific Affairs, LLC

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ustekinumab
  • Other Biologic Therapies

Treatment groups

1,056 Participants
are divided into 2 treatment groups