A Study of Ustekinumab Treatment in Children With Crohn's Disease

Completed

Conditions studied: Crohn's Disease

In brief

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 weight \>= 40 kilograms \[kg\] at baseline).

Key facts

Study ID

NCT05242458

Run by

Janssen Research & Development, LLC

People needed

545

Starts

2022-03-21

Expected to finish

2023-05-22

Last updated by the study team

2025-05-13

Who can join

Age: 2 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Documented exposure to ustekinumab before enrollment in ICN (by chart review)

Where it is running

• ImproveCareNow, Inc. — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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