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NCT Number: NCT07520747

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

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.

Recruiting

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sungkyunkwan University Research and Business Foundation

Suwon, 16419, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Crude and Age-Adjusted Annual Prevalence in Pediatric CD

    Time frame: 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.

  4. Crude and Age-Adjusted Annual Prevalence in Pediatric UC

    Time frame: 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.

  5. Incidence of CD by Age-Stratified Groups

    Time frame: 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.

  6. Incidence of UC by Age-Stratified Groups

    Time frame: 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.

  7. Prevalence of CD by Age-Stratified Groups

    Time frame: 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.

  8. Prevalence of UC by Age-Stratified Groups

    Time frame: 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.

  9. Percentage of Participants Whose Primary Diagnosis Switched Between CD and UC

    Time frame: 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.

  10. Initial Treatment Types by Age-Stratified Group

    Time frame: 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.

  11. Subsequent Treatment Sequences by Age-Stratified Group

    Time frame: 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.

  12. Cumulative Persistence Rates for Biologic Drugs

    Time frame: 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.

  13. Time to Discontinuation

    Time frame: 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.

  14. Number of Hospitalizations

    Time frame: From index date to follow-up (Up to 13 years)

    Number of hospitalizations both overall and by age groups will be reported.

  15. Length of Hospitalization

    Time frame: From index date to follow-up (Up to 13 years)

    Length of hospitalization both overall and by age groups will be reported.

  16. Number of Emergency Department (ED) Visit

    Time frame: From index date to follow-up (Up to 13 years)

    Number of ED visits both overall and by age groups will be reported.

  17. Number of Outpatient Visits

    Time frame: From index date to follow-up (Up to 13 years)

    Number of outpatient visits both overall and by age groups will be reported.

  18. Number of Inflammatory Bowel Disease (IBD) Related Surgeries

    Time frame: From index date to follow-up (Up to 13 years)

    Number of IBD related surgeries both overall and by age groups will be reported.

  19. Number of Inpatient and Outpatient Visits to Non-Gastroenterology (GI) Departments

    Time frame: 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.

  20. Medical Costs

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

Epidemiology, Treatment Patterns, and Healthcare Resource Utilization in Pediatric Patients Under 18 Years of Age With Inflammatory Bowel Diseases in Korea: A Claims Database Study

Acronym: Ped IBD Claims

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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