An observational study in Crohn's Disease, sponsored by Janssen Research & Development, LLC. Completed at 1 site in United States. Open to participants aged 2 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Janssen Research & Development, LLC · Observational
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).
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 545 is above the median of 162 across 608 observational studies indexed under Crohn Disease.
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Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
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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.
Exclusion Criteria:
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
No interventions will be administered as a part of this study. Participants will receive ustekinumab as per their routine clinical practice.
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.
Time frame: Week 52
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.
Time frame: Week 52
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.
Time frame: Week 52
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.
Time frame: Week 52
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.
Time frame: Week 52
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.
Time frame: Week 52
Cohorts 1 and 7: Change from Baseline in Height at Week 52
Change from baseline in height at Week 52 will be reported.
Time frame: Baseline and Week 52
Cohorts 1 and 7: Change from Baseline in Weight at Week 52
Change from baseline in weight at Week 52 will be reported.
Time frame: Baseline and Week 52
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.
Time frame: Baseline and Week 52
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.
Time frame: Week 52
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.
Time frame: Baseline to Week 52
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.
Time frame: Week 52
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.
Time frame: Up to Week 52
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.
Time frame: Up to Week 52
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.
Time frame: Up to Week 52
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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