- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04372108
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
April 23, 2024 updated by: Janssen Scientific Affairs, LLC
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
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1056
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Contact
- Phone Number: 844-434-4210
- Email: Participate-In-This-Study@its.jnj.com
Study Locations
-
-
Virginia
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Portsmouth, Virginia, United States, 23708
- Recruiting
- NMCP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
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).
|
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).
|
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
Time Frame: 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.
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Up to 10 years and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opportunistic Infection (OI)
Time Frame: 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.
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Up to 10 years and 3 months
|
Serious Infection
Time Frame: 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.
|
Up to 10 years and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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 (Estimated)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR108561
- RRA-18896 (Other Identifier: Janssen Scientific Affairs, 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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