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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04372108
• Other study ID #: CR108561
• Secondary ID: RRA-18896
• Status: Recruiting
• Start date: June 24, 2021
• Est. completion date: August 30, 2030

Study information

• Verified date: June 2024
• Source: Janssen Scientific Affairs, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1056
• Est. completion date: August 30, 2030
• Est. primary completion date: August 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Ulcer

Intervention

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 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.

Locations

Country	Name	City	State
United States	NMCP	Portsmouth	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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