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

NCT07520747 | Recruiting

• 1 other identifier: CNTO1275IBD4014
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (20)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

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

• Subsequent Treatment Sequences by Age-Stratified Group

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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)

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (1)

Sungkyunkwan University Research and Business Foundation

Suwon, 16419, South Korea

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 7, 2026
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)