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

Recruiting

• Conditions: Crohn Disease; Colitis, Ulcerative
• Interventions: Drug: Ustekinumab; Drug: Other Biologic Therapies

• Registration Number: NCT04372108
• Lead Sponsor: Janssen Scientific Affairs, LLC

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-04-30
• Study First Posted: 2020-05-01
• Study Start: 2021-06-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2029-08-31
• Study Completion: 2030-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1056

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ustekinumab New User Cohort	Ustekinumab	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	Other Biologic Therapies	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).

Primary Outcome Measures

Name	Time	Method
Incidence Rate for Malignancy	Up 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NMCP; 🇺🇸 Portsmouth, Virginia, United States