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A gyermekek gyulladásos bélbetegségeinek adatbázis-vizsgálata Koreában: betegségek, kezelési minták és egészségügyi ellátás (Ped IBD Claims)

2026. november 2. frissítette: Janssen Korea, Ltd., Korea

A koreai gyulladásos bélbetegségben szenvedő 18 év alatti gyermekek epidemiológiája, kezelési mintázatai és egészségügyi erőforrás-felhasználása: Jogcímadatbázis-vizsgálat

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.

A tanulmány áttekintése

Állapot

Aktív, nem toborzó

Körülmények

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

8000

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

Nem régebbi, mint 17 év (Gyermek)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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).

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Megfigyelési modellek: COHORT
  • Időperspektívák: RETROSPECTIVE

Kohorszok és beavatkozások

Csoport / Kohorsz
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Janssen Korea, Ltd., Korea

Nyomozók

  • Tanulmányi igazgató: Janssen Korea, Ltd. Clinical Trial, Janssen Korea, Ltd.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. április 7.

Elsődleges befejezés (Becsült)

2026. október 30.

A tanulmány befejezése (Becsült)

2026. október 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. április 2.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. április 2.

Első közzététel (Tényleges)

2026. április 9.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. november 3.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 2.

Utolsó ellenőrzés

2026. november 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • CNTO1275IBD4014

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

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.

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

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