Disease, treatment patterns, and healthcare use in Korean children with inflammatory bowel diseases
Epidemiology, Treatment Patterns, and Healthcare Resource Utilization in Pediatric Patients Under 18 Years of Age With Inflammatory Bowel Diseases in Korea: A Claims Database Study
This project will see how Korean children with Crohn's disease or ulcerative colitis are diagnosed, treated as they grow, and how often they use healthcare services.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8000 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Janssen Korea, Ltd., Korea Industry-sponsored |
| Locations | 1 site (Suwon) |
| Trial ID | NCT07520747 on ClinicalTrials.gov |
What this trial studies
This observational database analysis uses Korean medical records to estimate how many children develop and live with Crohn's disease and ulcerative colitis, with results stratified by age. Cases are identified using ICD-10 codes (K50.x for CD, K51.x for UC), rare disease registry codes (V130/V131), and medication records, requiring at least two outpatient or one inpatient diagnosis plus an IBD medication prescription during the index period. The study tracks longitudinal treatment patterns (including 5-ASA, exclusive enteral nutrition, corticosteroids, immunomodulators, and biologics), how regimens change as children age, and healthcare utilization and costs over several years. Data analysis is performed using records available to Sungkyunkwan University and sponsored by Janssen Korea.
Who should consider this trial
Good fit: Children in Korea diagnosed with Crohn's disease or ulcerative colitis whose care appears in national medical records and who have the required diagnostic codes and at least one IBD medication prescription are eligible.
Not a fit: Children without documented ICD-10 codes for CD or UC, without IBD medication prescriptions, or whose care occurs outside the covered Korean databases are unlikely to be included or benefit.
Why it matters
Potential benefit: If successful, the findings could help clinicians and policymakers improve treatment pathways and resource planning for children with IBD in Korea.
How similar studies have performed: Similar national database analyses in other countries have reliably described pediatric IBD incidence, treatment trends, and costs, so this method is well established rather than novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with at least two outpatient or one inpatient diagnosis codes for the same disease type (either CD or UC) using international classification of diseases, tenth revision (ICD-10) codes (K50. X for CD and K51. X for UC) recorded as primary or the first secondary diagnosis, and the codes for rare and intractable disease registration program (V130 for CD, V131 for UC) during the index period * Participants who received at least one prescription for conventional pediatric inflammatory bowel disease (IBD)-related medications (for example, 5-aminosalicylic acids \[5-ASAs\], exclusive enteral nutrition \[EENs\], corticosteroids, immunomodulators, or biologic drugs) during the index period Exclusion Criteria: \- No specific exclusion criteria are defined in this study
Where this trial is running
Suwon
- Sungkyunkwan University Research and Business Foundation — Suwon, South Korea (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.