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

Crohn's Disease Clinical Trial

— REALITI  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242458
• Other study ID #: CR109167
• Secondary ID: CNTO1275CRD3010
• Status: Completed
• Start date: March 21, 2022
• Est. completion date: May 22, 2023

Study information

• Verified date: July 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: May 22, 2023
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
United States	ImproveCareNow, Inc.,	Burlington	Vermont

Sponsors (3)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC	Children's Hospital Medical Center, Cincinnati, ImproveCareNow (ICN)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1: Percentage of Pediatric Participants with Clinical Remission at 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.	Week 52
Secondary	Cohort 7: Percentage of Young Adult Participants with Clinical Remission at Week 52	Percentage of young adult participants with clinical remission at Week 52 will be reported.	Week 52
Secondary	Cohorts 2, 3, 4, 5, 6, 8 and 9: Percentage of Participants with Clinical Remission at Week 52	Percentage of participants with clinical remission at Week 52 will be reported.	Week 52
Secondary	Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 Evaluated by Ustekinumab Dose Bands	Percentage of participants with clinical remission at Week 52 evaluated by ustekinumab dose bands will be reported.	Week 52
Secondary	Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 with No Corticosteroid Use	Percentage of participants with clinical remission at Week 52 with no corticosteroid use will be reported.	Week 52
Secondary	Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 by PGA Score	Percentage of participants with clinical remission at Week 52 by Physician Global Assessment (PGA) score will be reported.	Week 52
Secondary	Cohorts 1 and 7: Change from Baseline in Height at Week 52	Change from baseline in height at Week 52 will be reported.	Baseline and Week 52
Secondary	Cohorts 1 and 7: Change from Baseline in Weight at Week 52	Change from baseline in weight at Week 52 will be reported.	Baseline and Week 52
Secondary	Cohorts 1 and 7: Change from Baseline in Body Mass Index (BMI) at Week 52	Change from baseline in BMI (measured with age and sex-specific z-scores) at Week 52 will be reported.	Baseline and Week 52
Secondary	Cohorts 1 and 7: Percentage of Participants Who Achieve Endoscopic Remission with SEMA-CD Score of 0 or 1 at 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.	Week 52
Secondary	Cohorts 1 and 7: Change from Baseline to Week 52 in Mucosal Disease Activity Measured with SEMA-CD Score	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.	Baseline to Week 52
Secondary	Cohorts 1 and 7: Percentage of Participants that Discontinued Ustekinumab Use Among Participants who Initiated Ustekinumab Therapy at Week 52	Percentage of participants that discontinued ustekinumab use among participants who initiated ustekinumab therapy at Week 52 will be reported.	Week 52
Secondary	Cohorts 1 and 7: Percentage of Participants with Occurrence of Inflammatory Bowel Diseases (IBD)-related Hospitalizations Who had Initiated Ustekinumab Therapy	Percentage of participants with occurrence of IBD-related hospitalizations who had initiated ustekinumab therapy will be reported.	Up to Week 52
Secondary	Cohorts 1 and 7: Percentage of Participants with Occurrence of IBD-related Surgeries Who had Initiated Ustekinumab Therapy	Percentage of participants with occurrence of IBD-related surgeries who had initiated ustekinumab therapy will be reported.	Up to Week 52
Secondary	Cohorts 1 and 7: Percentage of Participants with Adverse Events of Special Interest (AESI) Who had Initiated Ustekinumab Therapy	Percentage of participants with AESIs (example: malignancies, serious and opportunistic infection, anaphylaxis requiring discontinuation of ustekinumab) who had initiated ustekinumab therapy will be reported.	Up to Week 52