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Een databaseonderzoek naar ziekte, behandelpatronen en gezondheidszorggebruik bij kinderen met inflammatoire darmziekten in Korea (Ped IBD Claims)

2 november 2026 bijgewerkt door: Janssen Korea, Ltd., Korea

Epidemiologie, behandelpatronen en gezondheidszorgresourcegebruik bij pediatrische patiënten jonger dan 18 jaar met inflammatoire darmziekten in Korea: Een claimsdatabankstudie

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

8000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Zuid -Korea
      • Suwon, Zuid -Korea, 16419
        • Sungkyunkwan University Research and Business Foundation

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Niet ouder dan 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population will be selected from the health insurance review and assessment (HIRA) database and include pediatric participants, who have been newly diagnosed or previously with either crohn's disease (CD) or ulcerative colitis (UC).

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: RETROSPECTIVE

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD)
Tijdsspanne: During the index period (2012 to 2023; up to 12 years)

The crude and age-adjusted annual incidence CD will be calculated in each calendar year. Annual incidence and the prevalence in the year of interest will be estimated using the number of newly diagnosed participants and the number of participants with the diagnosis within the corresponding year, respectively.
During the index period (2012 to 2023; up to 12 years)
Crude and Age-Adjusted Annual Incidence in Pediatric Ulcerative Colitis (UC)
Tijdsspanne: During the index period (2012 to 2023; up to 12 years)

The crude and age-adjusted annual incidence UC will be calculated in each calendar year. Annual incidence and the prevalence in the year of interest will be estimated using the number of newly diagnosed participants and the number of participants with the diagnosis within the corresponding year, respectively.
During the index period (2012 to 2023; up to 12 years)
Crude and Age-Adjusted Annual Prevalence in Pediatric CD
Tijdsspanne: During the index period (2012 to 2023; up to 12 years)

The crude and age-adjusted annual prevalence CD will be calculated in each calendar year. Annual incidence and the prevalence in the year of interest will be estimated using the number of newly diagnosed participants and the number of participants with the diagnosis within the corresponding year, respectively.
During the index period (2012 to 2023; up to 12 years)
Crude and Age-Adjusted Annual Prevalence in Pediatric UC
Tijdsspanne: During the index period (2012 to 2023; up to 12 years)

The crude and age-adjusted annual prevalence UC will be calculated in each calendar year. Annual incidence and the prevalence in the year of interest will be estimated using the number of newly diagnosed participants and the number of participants with the diagnosis within the corresponding year, respectively.
During the index period (2012 to 2023; up to 12 years)
Incidence of CD by Age-Stratified Groups
Tijdsspanne: During the index period (2012 to 2023; up to 12 years)

Incidence of CD stratified by age-specific subgroups (0 to less than [<] 6 years old, 6 to <10 years old, and 10 to <18 years old) will be reported.
During the index period (2012 to 2023; up to 12 years)
Incidence of UC by Age-Stratified Groups
Tijdsspanne: During the index period (2012 to 2023; up to 12 years)

Incidence of UC stratified by age-specific subgroups (0 to <6 years old, 6 to <10 years old, and 10 to <18 years old) will be reported.
During the index period (2012 to 2023; up to 12 years)
Prevalence of CD by Age-Stratified Groups
Tijdsspanne: During the index period (2012 to 2023; up to 12 years)

Prevalence of CD stratified by age-specific subgroups (0 to <6 years old, 6 to <10 years old, and 10 to <18 years old) will be reported.
During the index period (2012 to 2023; up to 12 years)
Prevalence of UC by Age-Stratified Groups
Tijdsspanne: During the index period (2012 to 2023; up to 12 years)

Prevalence of UC stratified by age-specific subgroups (0 to <6 years old, 6 to <10 years old, and 10 to <18 years old) will be reported.
During the index period (2012 to 2023; up to 12 years)
Percentage of Participants Whose Primary Diagnosis Switched Between CD and UC
Tijdsspanne: During the index period (2012 to 2023; up to 12 years)

Percentage of participants whose primary diagnosis switched at least once between CD and UC during the follow-up period will be reported.
During the index period (2012 to 2023; up to 12 years)
Initial Treatment Types by Age-Stratified Group
Tijdsspanne: From index date to follow-up (Up to 13 years)

Initial treatment types by age-stratified groups (0 to <6 years old, 6 to <10 years old, and 10 to <18 years old on the index date) will be reported.
From index date to follow-up (Up to 13 years)
Subsequent Treatment Sequences by Age-Stratified Group
Tijdsspanne: From index date to follow-up (Up to 13 years)

Subsequent treatment sequences by age-stratified groups (0 to <6 years old, 6 to <10 years old, and 10 to <18 years old on the index date) will be reported.
From index date to follow-up (Up to 13 years)
Cumulative Persistence Rates for Biologic Drugs
Tijdsspanne: From index date to follow-up (Up to 13 years)

Cumulative persistence rates for biologic drugs is defined as continuous use of the same biologic drug without a pre-defined biologic free interval (that is, 90 days or more) between prescription claims.
From index date to follow-up (Up to 13 years)
Time to Discontinuation
Tijdsspanne: From index date to follow-up (Up to 13 years)

Discontinuation (non-persistence) will be defined as experiencing one of the following cases: stop: a case where biologic drug was prescribed with a gap of greater than or equal to (>=) 90 days from the discontinuation date of the previous prescription OR no further biologic drug was prescribed until the end of study period from the discontinuation date of the index drug; switch: a case where a different biologic drug was prescribed after the initial drug; re-initiation: a case where the same biologic drug was prescribed again after >=90 days.
From index date to follow-up (Up to 13 years)
Number of Hospitalizations
Tijdsspanne: From index date to follow-up (Up to 13 years)

Number of hospitalizations both overall and by age groups will be reported.
From index date to follow-up (Up to 13 years)
Length of Hospitalization
Tijdsspanne: From index date to follow-up (Up to 13 years)

Length of hospitalization both overall and by age groups will be reported.
From index date to follow-up (Up to 13 years)
Number of Emergency Department (ED) Visit
Tijdsspanne: From index date to follow-up (Up to 13 years)

Number of ED visits both overall and by age groups will be reported.
From index date to follow-up (Up to 13 years)
Number of Outpatient Visits
Tijdsspanne: From index date to follow-up (Up to 13 years)

Number of outpatient visits both overall and by age groups will be reported.
From index date to follow-up (Up to 13 years)
Number of Inflammatory Bowel Disease (IBD) Related Surgeries
Tijdsspanne: From index date to follow-up (Up to 13 years)

Number of IBD related surgeries both overall and by age groups will be reported.
From index date to follow-up (Up to 13 years)
Number of Inpatient and Outpatient Visits to Non-Gastroenterology (GI) Departments
Tijdsspanne: From index date to follow-up (Up to 13 years)

Number of inpatient and outpatient visits to non-GI departments both overall and by age groups will be reported.
From index date to follow-up (Up to 13 years)
Medical Costs
Tijdsspanne: From index date to follow-up (Up to 13 years)

Medical costs including inpatient, outpatient and pharmacy costs, both overall and by age groups, will be reported.
From index date to follow-up (Up to 13 years)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Korea, Ltd., Korea

Onderzoekers

  • Studie directeur: Janssen Korea, Ltd. Clinical Trial, Janssen Korea, Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 april 2026

Primaire voltooiing (Geschat)

30 oktober 2026

Studie voltooiing (Geschat)

30 oktober 2026

Studieregistratiedata

Eerst ingediend

2 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 april 2026

Eerst geplaatst (Werkelijk)

9 april 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CNTO1275IBD4014

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

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