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NCT05242458 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Janssen Research & Development.

Completed
Registry status
545
Enrollment target

NCT05242458: Completed study, sponsored by Janssen Research & Development.

NCT05242458 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 545 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05242458 has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
545 participants
Enrollment target

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

Primary Outcome

Percentage of Pediatric participants with clinical remission at Week 52 will be reported. Clinical remission is defined by short pediatric Crohn's disease activity index (sPCDAI) less than or equal to (\<=) 10.

Interventions

  • DRUG Ustekinumab

Trial Details

FieldValue
Enrollment Target 545 participants
Start Date 2022-03-21
Est. Completion 2023-05-22
Janssen Research & Development

593 total trials

What the finished NCT05242458 record still lists

NCT05242458 is an observational study that tracks outcomes without assigning an intervention. The registered 545 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Ustekinumab is the first listed.

NCT05242458 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05242458 about?

NCT05242458 is a clinical study titled "A Study of Ustekinumab Treatment in Children With Crohn's Disease". 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).

What is the current status of trial NCT05242458?

This trial is currently completed. The enrollment target is 545 participants. The study started on 2022-03-21. Estimated completion is 2023-05-22.

What interventions are being tested in trial NCT05242458?

The interventions under investigation include: Ustekinumab (DRUG).

Who is sponsoring clinical trial NCT05242458?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05242458, the US trial registry maintained by the National Library of Medicine. NCT05242458 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.