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Ped IBD ClaimsNCT07520747

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

StatusActive, Not Recruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved at least 2 months later across 2 updates.

See at-risk trials from Johnson & Johnson

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Record History

All 7 versions: 6 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 20 entries Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Primary and study completion pushed from Aug 31, 2026 to Oct 30, 2026
    • Site details revised
    • Eligibility criteria expanded, about 2 words
  2. Primary and study completion pushed from Jul 31, 2026 to Aug 31, 2026v6
  3. Primary and study completion dates pushed to Jul 31, 2026v5
  4. Study completion date: Jun 20, 2026 to Jun 29, 2026v3
  5. Start date changed from estimate of Apr 6, 2026 to Apr 7, 2026v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD)
Timeframe: During the index period (2012 to 2023; up to 12 years)
Crude and Age-Adjusted Annual Incidence in Pediatric Ulcerative Colitis (UC)
Timeframe: During the index period (2012 to 2023; up to 12 years)
Crude and Age-Adjusted Annual Prevalence in Pediatric CD
Timeframe: During the index period (2012 to 2023; up to 12 years)
Crude and Age-Adjusted Annual Prevalence in Pediatric UC
Timeframe: During the index period (2012 to 2023; up to 12 years)
Incidence of CD by Age-Stratified Groups
Timeframe: During the index period (2012 to 2023; up to 12 years)
Incidence of UC by Age-Stratified Groups
Timeframe: During the index period (2012 to 2023; up to 12 years)
Prevalence of CD by Age-Stratified Groups
Timeframe: During the index period (2012 to 2023; up to 12 years)
Prevalence of UC by Age-Stratified Groups
Timeframe: During the index period (2012 to 2023; up to 12 years)
Percentage of Participants Whose Primary Diagnosis Switched Between CD and UC
Timeframe: During the index period (2012 to 2023; up to 12 years)
Initial Treatment Types by Age-Stratified Group
Timeframe: From index date to follow-up (Up to 13 years)
Subsequent Treatment Sequences by Age-Stratified Group
Timeframe: From index date to follow-up (Up to 13 years)
Cumulative Persistence Rates for Biologic Drugs
Timeframe: From index date to follow-up (Up to 13 years)
Time to Discontinuation
Timeframe: From index date to follow-up (Up to 13 years)
Number of Hospitalizations
Timeframe: From index date to follow-up (Up to 13 years)
Length of Hospitalization
Timeframe: From index date to follow-up (Up to 13 years)
Number of Emergency Department (ED) Visit
Timeframe: From index date to follow-up (Up to 13 years)
Number of Outpatient Visits
Timeframe: From index date to follow-up (Up to 13 years)
Number of Inflammatory Bowel Disease (IBD) Related Surgeries
Timeframe: From index date to follow-up (Up to 13 years)
Number of Inpatient and Outpatient Visits to Non-Gastroenterology (GI) Departments
Timeframe: From index date to follow-up (Up to 13 years)
Medical Costs
Timeframe: From index date to follow-up (Up to 13 years)

Arms and interventions

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.

Sites

1 site in 1 country

  • Sungkyunkwan University Research and Business FoundationSuwon, South Korea