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

NCT04372108 | Recruiting

• 2 other identifiers: CR108561RRA-18896
• Study Type: observational
• Target: 1,056
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Opportunistic Infection (OI)

  Up to 10 years and 3 months

• Serious Infection

  Up to 10 years and 3 months

Study Arms (2)

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

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

Interventions

Ustekinumab DRUG

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.

Ustekinumab New User Cohort

Other Biologic Therapies DRUG

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.

Other Biologics Comparator Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead

Study Sites (1)

NMCP

Portsmouth, Virginia, 23708, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Scientific Affairs, LLC Clinical Trial

  Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 1, 2020
• Study Start: June 24, 2021
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 30, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)