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Long-Term Safety of Ustekinumab for Crohn's Disease and Ulcerative Colitis

This study is looking at the long-term safety of ustekinumab compared to other biologic therapies (like infliximab, adalimumab, or vedolizumab) in adults with Crohn's disease (CD) or ulcerative colitis (UC). Researchers want to see if there are differences in the rates of cancer and serious infections between people who start taking ustekinumab and those who start other biologics. You could be eligible if you are an adult with CD or UC and are a new user of one of these medications, with at least one year of medical history in the DoD (Department of Defense) health system. The study will track these health outcomes for up to 10 years and 3 months. The current status of this study is unclear.

Study design
This is an observational study involving 1056 participants. It compares health outcomes in people already taking ustekinumab or other biologic therapies.
What's involved
No study treatment will be given as part of this study. Your existing medical records will be used for research.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years and 3 months to track the incidence of malignancy (cancer).

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NCT04372108

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

Recruiting
Not specifiedAges 18+Observational
Janssen Scientific Affairs, LLC
~1,536 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:UstekinumabOther Biologic Therapies

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence Rate for Malignancy
Measured over Up to 10 years and 3 months

Conditions

Crohn Disease
Colitis, Ulcerative

Explore related trials

Crohn DiseaseUlcerative Colitis

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Janssen Scientific Affairs, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Scientific Affairs, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Incidence Rate for MalignancyUp to 10 years and 3 months

    The incidence rates for malignancy (including Non-melanoma skin cancer \[NMSC\]) will be estimated as the number of incident cases (that is, counts of unique participants) divided by the total at-risk time.