Databázová studie onemocnění, léčebných postupů a využití zdravotní péče u dětí se zánětlivými střevními onemocněními v Koreji (Ped IBD Claims)
Epidemiologie, léčebné postupy a využívání zdravotnických zdrojů u pediatrických pacientů mladších 18 let se zánětlivými střevními onemocněními v Koreji: Studie z databáze pojistných nároků
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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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Suwon, Jižní Korea, 16419
- Sungkyunkwan University Research and Business Foundation
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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).
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: RETROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD)
Časové okno: During the index period (2012 to 2023; up to 12 years)
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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)
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Crude and Age-Adjusted Annual Incidence in Pediatric Ulcerative Colitis (UC)
Časové okno: During the index period (2012 to 2023; up to 12 years)
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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)
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Crude and Age-Adjusted Annual Prevalence in Pediatric CD
Časové okno: During the index period (2012 to 2023; up to 12 years)
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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)
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Crude and Age-Adjusted Annual Prevalence in Pediatric UC
Časové okno: During the index period (2012 to 2023; up to 12 years)
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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)
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Incidence of CD by Age-Stratified Groups
Časové okno: During the index period (2012 to 2023; up to 12 years)
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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)
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Incidence of UC by Age-Stratified Groups
Časové okno: During the index period (2012 to 2023; up to 12 years)
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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)
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Prevalence of CD by Age-Stratified Groups
Časové okno: During the index period (2012 to 2023; up to 12 years)
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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)
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Prevalence of UC by Age-Stratified Groups
Časové okno: During the index period (2012 to 2023; up to 12 years)
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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)
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Percentage of Participants Whose Primary Diagnosis Switched Between CD and UC
Časové okno: During the index period (2012 to 2023; up to 12 years)
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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)
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Initial Treatment Types by Age-Stratified Group
Časové okno: From index date to follow-up (Up to 13 years)
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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)
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Subsequent Treatment Sequences by Age-Stratified Group
Časové okno: From index date to follow-up (Up to 13 years)
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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)
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Cumulative Persistence Rates for Biologic Drugs
Časové okno: From index date to follow-up (Up to 13 years)
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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)
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Time to Discontinuation
Časové okno: From index date to follow-up (Up to 13 years)
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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)
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Number of Hospitalizations
Časové okno: From index date to follow-up (Up to 13 years)
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Number of hospitalizations both overall and by age groups will be reported. |
From index date to follow-up (Up to 13 years)
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Length of Hospitalization
Časové okno: From index date to follow-up (Up to 13 years)
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Length of hospitalization both overall and by age groups will be reported. |
From index date to follow-up (Up to 13 years)
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Number of Emergency Department (ED) Visit
Časové okno: From index date to follow-up (Up to 13 years)
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Number of ED visits both overall and by age groups will be reported. |
From index date to follow-up (Up to 13 years)
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Number of Outpatient Visits
Časové okno: From index date to follow-up (Up to 13 years)
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Number of outpatient visits both overall and by age groups will be reported. |
From index date to follow-up (Up to 13 years)
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Number of Inflammatory Bowel Disease (IBD) Related Surgeries
Časové okno: From index date to follow-up (Up to 13 years)
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Number of IBD related surgeries both overall and by age groups will be reported. |
From index date to follow-up (Up to 13 years)
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Number of Inpatient and Outpatient Visits to Non-Gastroenterology (GI) Departments
Časové okno: From index date to follow-up (Up to 13 years)
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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)
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Medical Costs
Časové okno: From index date to follow-up (Up to 13 years)
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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)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Janssen Korea, Ltd. Clinical Trial, Janssen Korea, Ltd.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CNTO1275IBD4014
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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