REALITI: A Study of Ustekinumab Treatment in Children With Crohn's Disease
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
No interventions will be administered as a part of this study. Participants will receive ustekinumab as per their routine clinical practice.
|
Outcome Measures
Primary Outcome Measures
- Cohort 1: Percentage of Pediatric Participants with Clinical Remission at Week 52 [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 Outcome Measures
- Cohort 7: Percentage of Young Adult Participants with Clinical Remission at Week 52 [Week 52]
Percentage of young adult participants with clinical remission at Week 52 will be reported.
- Cohorts 2, 3, 4, 5, 6, 8 and 9: Percentage of Participants with Clinical Remission at Week 52 [Week 52]
Percentage of participants with clinical remission at Week 52 will be reported.
- Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 Evaluated by Ustekinumab Dose Bands [Week 52]
Percentage of participants with clinical remission at Week 52 evaluated by ustekinumab dose bands will be reported.
- Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 with No Corticosteroid Use [Week 52]
Percentage of participants with clinical remission at Week 52 with no corticosteroid use will be reported.
- Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 by PGA Score [Week 52]
Percentage of participants with clinical remission at Week 52 by Physician Global Assessment (PGA) score will be reported.
- Cohorts 1 and 7: Change from Baseline in Height at Week 52 [Baseline and Week 52]
Change from baseline in height at Week 52 will be reported.
- Cohorts 1 and 7: Change from Baseline in Weight at Week 52 [Baseline and Week 52]
Change from baseline in weight at Week 52 will be reported.
- Cohorts 1 and 7: Change from Baseline in Body Mass Index (BMI) at Week 52 [Baseline and Week 52]
Change from baseline in BMI (measured with age and sex-specific z-scores) at Week 52 will be reported.
- Cohorts 1 and 7: Percentage of Participants Who Achieve Endoscopic Remission with SEMA-CD Score of 0 or 1 at Week 52 [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.
- Cohorts 1 and 7: Change from Baseline to Week 52 in Mucosal Disease Activity Measured with SEMA-CD Score [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.
- Cohorts 1 and 7: Percentage of Participants that Discontinued Ustekinumab Use Among Participants who Initiated Ustekinumab Therapy at Week 52 [Week 52]
Percentage of participants that discontinued ustekinumab use among participants who initiated ustekinumab therapy at Week 52 will be reported.
- Cohorts 1 and 7: Percentage of Participants with Occurrence of Inflammatory Bowel Diseases (IBD)-related Hospitalizations Who had Initiated Ustekinumab Therapy [Up to Week 52]
Percentage of participants with occurrence of IBD-related hospitalizations who had initiated ustekinumab therapy will be reported.
- Cohorts 1 and 7: Percentage of Participants with Occurrence of IBD-related Surgeries Who had Initiated Ustekinumab Therapy [Up to Week 52]
Percentage of participants with occurrence of IBD-related surgeries who had initiated ustekinumab therapy will be reported.
- Cohorts 1 and 7: Percentage of Participants with Adverse Events of Special Interest (AESI) Who had Initiated Ustekinumab Therapy [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.
Eligibility Criteria
Criteria
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
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Having at least one ICN visit prior to the ICN visit when ustekinumab is first documented
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Having received first dose of ustekinumab on or before June 22, 2019
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ImproveCareNow, Inc. | Burlington | Vermont | United States | 05408 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
- ImproveCareNow (ICN)
- Children's Hospital Medical Center, Cincinnati
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109167
- CNTO1275CRD3010