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Completed

NCT Number: NCT05242458

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).

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

2 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ImproveCareNow, Inc.

Burlington, Vermont, 05408, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

Ustekinumab

Drug

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

Primary outcomes

  1. Cohort 1: Percentage of Pediatric Participants with Clinical Remission at Week 52

    Time frame: Week 52

    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.

Secondary outcomes

  1. Cohort 7: Percentage of Young Adult Participants with Clinical Remission at Week 52

    Time frame: Week 52

    Percentage of young adult participants with clinical remission at Week 52 will be reported.

  2. Cohorts 2, 3, 4, 5, 6, 8 and 9: Percentage of Participants with Clinical Remission at Week 52

    Time frame: Week 52

    Percentage of participants with clinical remission at Week 52 will be reported.

  3. Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 Evaluated by Ustekinumab Dose Bands

    Time frame: Week 52

    Percentage of participants with clinical remission at Week 52 evaluated by ustekinumab dose bands will be reported.

  4. Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 with No Corticosteroid Use

    Time frame: Week 52

    Percentage of participants with clinical remission at Week 52 with no corticosteroid use will be reported.

  5. Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 by PGA Score

    Time frame: Week 52

    Percentage of participants with clinical remission at Week 52 by Physician Global Assessment (PGA) score will be reported.

  6. Cohorts 1 and 7: Change from Baseline in Height at Week 52

    Time frame: Baseline and Week 52

    Change from baseline in height at Week 52 will be reported.

  7. Cohorts 1 and 7: Change from Baseline in Weight at Week 52

    Time frame: Baseline and Week 52

    Change from baseline in weight at Week 52 will be reported.

  8. Cohorts 1 and 7: Change from Baseline in Body Mass Index (BMI) at Week 52

    Time frame: Baseline and Week 52

    Change from baseline in BMI (measured with age and sex-specific z-scores) at Week 52 will be reported.

  9. Cohorts 1 and 7: Percentage of Participants Who Achieve Endoscopic Remission with SEMA-CD Score of 0 or 1 at Week 52

    Time frame: Week 52

    Percentage of participants who achieve endoscopic remission with simplified endoscopic mucosal assessment for Crohn's disease (SEMA-CD) score of 0 or 1 at Week 52 will be reported. Endoscopic remission is defined as SEMA-CD score of 0 or 1. SEMA-CD mucosal disease activity score is defined as inactive = 0; minimal = 1; mild = 2-4; moderate = 5-9, or severe = greater than or equal to (>=) 10.

  10. Cohorts 1 and 7: Change from Baseline to Week 52 in Mucosal Disease Activity Measured with SEMA-CD Score

    Time frame: Baseline to Week 52

    Change from baseline to Week 52 in mucosal disease activity measured with SEMA-CD score will be reported. SEMA-CD mucosal disease activity score is defined as inactive = 0; minimal = 1; mild = 2-4; moderate = 5-9, or severe = greater than or equal to (>=) 10.

  11. Cohorts 1 and 7: Percentage of Participants that Discontinued Ustekinumab Use Among Participants who Initiated Ustekinumab Therapy at Week 52

    Time frame: Week 52

    Percentage of participants that discontinued ustekinumab use among participants who initiated ustekinumab therapy at Week 52 will be reported.

  12. Cohorts 1 and 7: Percentage of Participants with Occurrence of Inflammatory Bowel Diseases (IBD)-related Hospitalizations Who had Initiated Ustekinumab Therapy

    Time frame: Up to Week 52

    Percentage of participants with occurrence of IBD-related hospitalizations who had initiated ustekinumab therapy will be reported.

  13. Cohorts 1 and 7: Percentage of Participants with Occurrence of IBD-related Surgeries Who had Initiated Ustekinumab Therapy

    Time frame: Up to Week 52

    Percentage of participants with occurrence of IBD-related surgeries who had initiated ustekinumab therapy will be reported.

  14. Cohorts 1 and 7: Percentage of Participants with Adverse Events of Special Interest (AESI) Who had Initiated Ustekinumab Therapy

    Time frame: Up to Week 52

    Percentage of participants with AESIs (example: malignancies, serious and opportunistic infection, anaphylaxis requiring discontinuation of ustekinumab) who had initiated ustekinumab therapy will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • ImproveCareNow (ICN)

Registry information

Official study title

Real-world Evidence for the Effectiveness and Safety of Ustekinumab Treatment in Children With Crohn's Disease: A Retrospective Cohort Study Using the ImproveCareNow Registry Data

Acronym: REALITI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2022
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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