База данных для изучения заболеваний, моделей лечения и использования медицинских услуг у детей с воспалительными заболеваниями кишечника в Корее (Ped IBD Claims)
Эпидемиология, модели лечения и использование ресурсов здравоохранения у педиатрических пациентов младше 18 лет с воспалительными заболеваниями кишечника в Корее: исследование базы данных страховых требований
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.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Места учебы
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Suwon, Южная Корея, 16419
- Sungkyunkwan University Research and Business Foundation
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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).
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: RETROSPECTIVE
Когорты и вмешательства
Группа / когорта |
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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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Janssen Korea, Ltd. Clinical Trial, Janssen Korea, Ltd.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CNTO1275IBD4014
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .