Status:
COMPLETED
A Study of Ustekinumab Treatment in Children With Crohn's Disease
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
ImproveCareNow (ICN)
Children's Hospital Medical Center, Cincinnati
Conditions:
Crohn's Disease
Eligibility:
All Genders
2-25 years
Brief Summary
The purpose of this study is to evaluate the effectiveness of ustekinumab in achieving clinical remission in pediatric participants (greater than or equal to \[\>=\] 2 to less than \[\<\] 18 years and...
Eligibility Criteria
Inclusion
- Having at least one ICN visit with documented new use of ustekinumab
- Participants with a documented Crohn's disease (CD) diagnosis at the time ustekinumab was initiated (that is, Baseline); If diagnosis at baseline is missing, then the diagnosis from previous visit within study window will be utilized
- Having at least one ICN visit prior to the ICN visit when ustekinumab is first documented
- Having received first dose of ustekinumab on or before June 22, 2019
- Having provided informed consent for use of ICN data for research purposes
Exclusion
- Documented exposure to ustekinumab before enrollment in ICN (by chart review)
Key Trial Info
Start Date :
March 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 22 2023
Estimated Enrollment :
545 Patients enrolled
Trial Details
Trial ID
NCT05242458
Start Date
March 21 2022
End Date
May 22 2023
Last Update
May 13 2025
Active Locations (1)
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1
ImproveCareNow, Inc.
Burlington, Vermont, United States, 05408