A Database Study of Disease, Treatment Patterns and Healthcare Use in Children With Inflammatory Bowel Diseases in Korea

N/ARecruitingNCT07520747

Janssen Korea, Ltd., Korea8,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

8,000

Conditions

Inflammatory Bowel Diseases

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD)

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.

Time frame: During the index period (2012 to 2023; up to 12 years)

Crude and Age-Adjusted Annual Incidence in Pediatric Ulcerative Colitis (UC)

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.

Time frame: During the index period (2012 to 2023; up to 12 years)

Crude and Age-Adjusted Annual Prevalence in Pediatric CD

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.

Time frame: During the index period (2012 to 2023; up to 12 years)

Crude and Age-Adjusted Annual Prevalence in Pediatric UC

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.

Time frame: During the index period (2012 to 2023; up to 12 years)

Incidence of CD by Age-Stratified Groups

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.

Time frame: During the index period (2012 to 2023; up to 12 years)

Incidence of UC by Age-Stratified Groups

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.

Time frame: During the index period (2012 to 2023; up to 12 years)

Prevalence of CD by Age-Stratified Groups

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.

Time frame: During the index period (2012 to 2023; up to 12 years)

Prevalence of UC by Age-Stratified Groups

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.

Time frame: During the index period (2012 to 2023; up to 12 years)

Percentage of Participants Whose Primary Diagnosis Switched Between CD and UC

Percentage of participants whose primary diagnosis switched at least once between CD and UC during the follow-up period will be reported.

Time frame: During the index period (2012 to 2023; up to 12 years)

Initial Treatment Types by Age-Stratified Group

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.