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The purpose of this study is:
CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system) and develop ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- No specific exclusion criteria are defined in this study
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sungkyunkwan University Research and Business Foundation | Recruiting | Suwon | 16419 | South Korea |
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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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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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) |