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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

545 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-21

Study Completion Date

2023-05-22

Brief Summary

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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).

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants with Crohn's Disease (CD)

Participants with moderate-to-severe active CD enrolled in ImproveCareNow (ICN) pediatric Inflammatory bowel disease (IBD) registry will be observed who are being treated with ustekinumab under real world setting and will be divided into 9 cohorts. Cohorts 1-6 for age group \>=2 to \<18 years (pediatric), cohorts 7-9 for young adults within age group \>=18 to \<26 years. Cohort 1: participants with moderate-severe CD and body weight \>=40 kg, cohort 2: participants with moderate-severe CD and body weight \<40 kg, cohort 3: all participants with moderate-severe CD, cohort 4: participants with active disease and body weight \>=40 kg, cohort 5: participants with active disease and body weight \<40 kg, cohort 6: all participants treated with ustekinumab, cohort 7: young adults with moderate-severe CD, cohort 8: young adults with active-disease; and cohort 9: all young adults treated with ustekinumab. Only data available per routine clinical practice will be collected within this study.

Ustekinumab

Intervention Type DRUG

No interventions will be administered as a part of this study. Participants will receive ustekinumab as per their routine clinical practice.

Interventions

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Ustekinumab

No interventions will be administered as a part of this study. Participants will receive ustekinumab as per their routine clinical practice.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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