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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04372108
Other study ID # CR108561
Secondary ID RRA-18896
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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