A Database Study of Disease, Treatment Patterns and Healthcare Use in Children With Inflammatory Bowel Diseases in Korea

Sponsor
Janssen Korea, Ltd., Korea
Study ID
NCT07520747
Status
Recruiting
Apply to this trial

Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Not accepted

Study Details

The purpose of this study is: * to find out out the number of children who develop crohn's disease (CD) and ulcerative colitis (UC) each year and are living with the disease and to see how this differs by age groups. * to understand how children of different age groups are treated over time and how their treatment changes as they grow. * to assess how often children use healthcare services and how much this costs for different age groups over several years. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system) and develop ulcers.

Key Dates

First listed
Apr 9, 2026
Start date
Apr 7, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
8,000 participants (estimated)

Arms

  • Arm: Group 1: Newly and Previously Diagnosed Pediatric Inflammatory Bowel Disease (IBD) Participants
    Participants, who have been either newly diagnosed or previously diagnosed with Crohn's disease (CD) or Ulcerative colitis (UC) will be enrolled. Data will be analyzed for epidemiology, baseline demographics and clinical characteristics, health care resource utilization profiles, and associated costs. Only newly diagnosed participants will be included in the analysis of longitudinal treatment patterns and incidence estimation. Only data available per routine clinical practice will be used in this study and will be de-identified and extracted from the health insurance review and assessment (HIRA) database.

Primary Outcome Measure

Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD) [ Time Frame: During the index period (2012 to 2023; up to 12 years) ]

Central Contacts

Related Studies