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

NCT05242458 | Completed FDA Drug

• 2 other identifiers: CR109167CNTO1275CRD3010
• Study Type: observational
• Target: 545
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

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

  Week 52

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

  Week 52

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

  Week 52

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

  Week 52

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

  Week 52

Study Arms (1)

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.

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

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

Participants with Crohn's Disease (CD)

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes pediatric participants (age greater than or equal to \[\>=\] 2 to less than \[\<\] 18 years with body weight \>=40 kilograms \[kg\]) and young adults (age \>= 18 to \< 26 years) with moderately to severely active Crohn's disease. The primary study population will be pediatric participants who have moderate to severe disease activity defined as short pediatric Crohn's disease activity index (sPCDAI) \>= 30, are treated with ustekinumab, and are followed at an ImproveCareNow (ICN) center.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• ImproveCareNow (ICN): collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (1)

ImproveCareNow, Inc.

Burlington, Vermont, 05408, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 16, 2022
• Study Start: March 21, 2022
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)