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韩国儿童炎症性肠病患者疾病、治疗模式及医疗资源利用的数据库研究 (Ped IBD Claims)

2026年11月2日更新者：Janssen Korea, Ltd., Korea

韩国18岁以下炎症性肠病儿科患者的流行病学、治疗模式及医疗资源利用：一项基于索赔数据库的研究

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.

研究概览

地位

主动，不招人

条件

炎症性肠病

研究类型

观察性的

注册 (估计的)

8000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

韩国
- - Suwon、韩国、16419
    - Sungkyunkwan University Research and Business Foundation

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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).

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：RETROSPECTIVE

团体/队列数

队列和干预

团体/队列
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.

团体/队列

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.

研究衡量的是什么？

主要结果指标

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Janssen Korea, Ltd., Korea

调查人员

研究主任：Janssen Korea, Ltd. Clinical Trial、Janssen Korea, Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月7日

初级完成 (估计的)

2026年10月30日

研究完成 (估计的)

2026年10月30日

研究注册日期

首次提交

2026年4月2日

首先提交符合 QC 标准的

2026年4月2日

首次发布 (实际的)

2026年4月9日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

结果测量	措施说明	大体时间
Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD) 大体时间：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) 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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)