Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the USA / NCT04372108
Recruiting Observational

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

NCT04372108 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Scientific Affairs, LLC
Phase
Observational
Started
2021-06-24
Last updated
2026-11-03

Condition(s) studied

Crohn DiseaseColitis, Ulcerative

Investigational drug(s) / intervention(s)

Ustekinumab →Other Biologic Therapies

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. Gaps in enrollment of ≤30 days will be considered continuous enrollment 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

Primary outcome measure(s)

  • 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.
  • Time from Treatment Initiation to First Diagnosed Malignancy — Up to 10 years and 3 months
    Time from treatment initiation to first diagnosed malignancy, including NMSC, while participant is alive will be reported.

Trial sites (1)

FacilityCityRegionStatus
BAMC Houston Texas Recruiting

On this site

📄 Stelara (ustekinumab) drug profile →

More Janssen Scientific Affairs, LLC trials in the USA

Psoriasis Longitudinal Assessment and Registry Active, not recruiting

Other trials for the same condition

A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically Recruiting
NaviCam Patency Capsule to Verify Gastrointestinal Patency Starting soon
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis Recruiting
A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease Active, not recruiting
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04372108 on ClinicalTrials.gov ↗ ← All trials in the USA