RecruitingNCT04372108

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

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


Sponsor

Janssen Scientific Affairs, LLC

Enrollment

1,056 participants

Start Date

Jun 24, 2021

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an observational study — no new treatment is given — that tracks real-world safety outcomes in people with Crohn's disease or ulcerative colitis who are starting a biologic medication. It compares the long-term safety of ustekinumab (Stelara) against other biologic drugs using military health records. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of Crohn's disease or ulcerative colitis - You are newly starting ustekinumab or a comparable biologic medication - You have at least one year of health records in the military's electronic health record system prior to starting the medication **You may NOT be eligible if...** - You are under 18 at the time of starting the medication - You do not have a confirmed diagnosis of Crohn's disease or ulcerative colitis - You have a history of HIV, organ transplant, or cancer (other than non-melanoma skin cancer) - You have been diagnosed with rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGUstekinumab

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.

DRUGOther 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(1)

NMCP

Portsmouth, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04372108


Related Trials