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

Part of paid clinical trials in Houston, Texas.

Sponsor
Janssen Scientific Affairs, LLC
Study ID
NCT04372108
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    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 — DRUG
    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 Details

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).

Key Dates

First listed
May 1, 2020
Start date
Jun 24, 2021
Status verified
Jul 2026
Primary completion
Aug 31, 2029
Completion
Aug 30, 2030

Study Design

Enrollment
1,056 participants (estimated)

Arms

  • Arm: 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).
  • Arm: 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).

Primary Outcome Measure

Incidence Rate for Malignancy [ Time Frame: Up to 10 years and 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
BAMCHoustonTexas78234-

Find similar trials in Houston, TX

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
BAMC· Houston, TX

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