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

An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database

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).

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Colitis, Ulcerative
• Intervention / Treatment: Drug: Ustekinumab; Drug: Other Biologic Therapies

• Study Type: Observational
• Enrollment (Estimated): 1056

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• United States
  • Virginia
    • Portsmouth, Virginia, United States, 23708
      • Recruiting
      • NMCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will include participants with Crohn's Disease (CD) or Ulcerative Colitis (UC) who are new users of ustekinumab and new users of the comparator drugs which will be identified from the Department of Defense (DoD) Electronic Health Records (EHR) database.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Drug: 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 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).	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate for Malignancy	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.	Up to 10 years and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opportunistic Infection (OI)	The OI will be estimated as the number of incident cases (that is counts of unique participants) divided by the total at-risk time.	Up to 10 years and 3 months
Serious Infection	The serious infections will be estimated as the number of incident cases (that is counts of unique participants) divided by the total at-risk time.	Up to 10 years and 3 months

Collaborators and Investigators

• Sponsor: Janssen Scientific Affairs, LLC
• Investigators: Study Director: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 30, 2030

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ustekinumab
• Other Study ID Numbers: CR108561; RRA-18896 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No