Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1275CRD3010 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ImproveCareNow (ICN) | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | No interventions will be administered as a part of this study. Participants will receive ustekinumab as per their routine clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cohorts 2, 3, 4, 5, 6, 8 and 9: Percentage of Participants with Clinical Remission at Week 52 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImproveCareNow, Inc. | Burlington | Vermont | 05408 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41766590 | Derived | Steiner SJ, Adler J, Saeed SA, Strauss RS, Howe KM, Sheahan A, Zhang R, Keihn KR, Harrow K, Olano KK, Evans DA, Lo KH, Zhang N, Kim L, Colletti RB, Volger S; ImproveCareNow Learning Health Network. Effectiveness and safety of ustekinumab in pediatric Crohn's disease: Results of the REALITI study. J Pediatr Gastroenterol Nutr. 2026 May;82(5):1242-1250. doi: 10.1002/jpn3.70372. Epub 2026 Mar 2. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Percentage of participants with clinical remission at Week 52 will be reported. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to Week 52 |
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |