Inflammatory Bowel DiseasesPed IBD ClaimsNCT07520747
A Database Study of Disease, Treatment Patterns and Healthcare Use in Children With Inflammatory Bowel Diseases in Korea
An observational study of Inflammatory Bowel Diseases, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 8,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Apr 2026to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- 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
Who cannot join
- No specific exclusion criteria are defined in this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Sungkyunkwan University Research and Business Foundation
Suwon, 16419
About this study
Official 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
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
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From index date to follow-up (Up to 13 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start7 Apr 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd. Clinical Trial, Study director, Janssen Korea, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520747
- Sponsor's protocol ID
- CNTO1275IBD4014
- Acronym
- Ped IBD Claims
- Status last verified
- Nov 2026
- First submitted
- 2 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07520747
- Acronym / sponsor ID
- Ped IBD Claims / CNTO1275IBD4014
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- No specific exclusion criteria are defined in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd. Clinical Trial study director
Janssen Korea, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.