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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorJanssen Korea, Ltd., Korea

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

8,000 Participants
are grouped into 1 trial group
Group A: Group 1: Newly and Previously Diagnosed Pediatric Inflammatory Bowel Disease (IBD) Participants

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)
4

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

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