Recruiting

Ustekinumab vs. Biologics

Sponsor:

Janssen Scientific Affairs, LLC

Code:

NCT04372108

Conditions

Crohn Disease

Colitis, Ulcerative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ustekinumab

Other Biologic Therapies

Study Details

Brief 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) or ulcerative colitis (UC).

Conditions

Crohn Disease

Colitis, Ulcerative

Study ID

NCT04372108

Start date

Jun 24, 2021

Status verified date

Aug, 2026

Completion date

Aug 30, 2030

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

1536 participants

Anticipated

Interventions and Outcome Measures

Arms

Ustekinumab New User Cohort

Participants with crohn's disease (CD) or ulcerative colitis (UC) with no prior exposure to ustekinumab, at least 1 year of enrollment records immediately prior to the new use will be required. The information will be sourced from the Department of Defense (DoD) Electronic Health Records (EHR) database in the United States (US).

Other Biologics Comparator Cohort

Participants with CD or UC with no prior exposure to the individual drugs (for example, infliximab, adalimumab, or vedolizumab) in question, at least 1 year of enrollment records immediately prior to the new use of the comparator biologic will be required. The information will be sourced from the Department of Defense (DoD) Electronic Health Records (EHR) database in the United States (US).

Interventions

Ustekinumab

Participants who are new users of ustekunumab will be included in the cohort. No study treatment will be administered as a part of this study.

Other Biologic Therapies

Participants who are new users of other biologic therapies (for examples for example, infliximab, adalimumab, or vedolizumab administered as per the prescription record) will be included in this cohort. No study treatment will be administered as a part of this study.

Primary outcome measure

  • Incidence Rate for Malignancy [ Time Frame: Up to 10 years and 3 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

BAMC

Recruiting

Houston, Texas, United States, 78234

More Information

Sponsor

Janssen Scientific Affairs, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Scientific Affairs, LLC on 2026-08-28.