Un Estudio de Base de Datos sobre la Enfermedad, Patrones de Tratamiento y Uso de la Atención Médica en Niños con Enfermedades Inflamatorias Intestinales en Corea (Ped IBD Claims)
Epidemiología, Patrones de Tratamiento y Utilización de Recursos Sanitarios en Pacientes Pediátricos Menores de 18 Años con Enfermedades Inflamatorias Intestinales en Corea: Un Estudio de Base de Datos de Reclamaciones
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Suwon, Corea del Sur, 16419
- Sungkyunkwan University Research and Business Foundation
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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).
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Korea, Ltd. Clinical Trial, Janssen Korea, Ltd.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CNTO1275IBD4014
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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