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

Part of paid clinical trials in Burlington, Vermont.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05242458
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Mar 21, 2022
Status verified
May 2025
Primary completion
May 22, 2023
Completion
May 22, 2023

Study Design

Enrollment
545 participants (actual)

Arms

  • Arm: 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.

Primary Outcome Measure

Cohort 1: Percentage of Pediatric Participants with Clinical Remission at Week 52 [ Time Frame: Week 52 ]

Locations (1)

FacilityCityStateZIPSite coordinators
ImproveCareNow, Inc.BurlingtonVermont05408-

Find similar trials in Burlington, VT

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
ImproveCareNow, Inc.· Burlington, VT

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