韓国における小児炎症性腸疾患の疾患、治療パターン、医療利用に関するデータベース研究 (Ped IBD Claims)
韓国における18歳未満の小児炎症性腸疾患患者の疫学、治療パターン、および医療資源利用状況：請求データベース研究
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.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Suwon、韓国、16419
- Sungkyunkwan University Research and Business Foundation
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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).
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：RETROSPECTIVE
コホートと介入
グループ/コホート |
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD)
時間枠：During the index period (2012 to 2023; up to 12 years)
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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)
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Crude and Age-Adjusted Annual Incidence in Pediatric Ulcerative Colitis (UC)
時間枠：During the index period (2012 to 2023; up to 12 years)
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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)
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Crude and Age-Adjusted Annual Prevalence in Pediatric CD
時間枠：During the index period (2012 to 2023; up to 12 years)
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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)
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Crude and Age-Adjusted Annual Prevalence in Pediatric UC
時間枠：During the index period (2012 to 2023; up to 12 years)
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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)
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Incidence of CD by Age-Stratified Groups
時間枠：During the index period (2012 to 2023; up to 12 years)
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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)
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Incidence of UC by Age-Stratified Groups
時間枠：During the index period (2012 to 2023; up to 12 years)
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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)
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Prevalence of CD by Age-Stratified Groups
時間枠：During the index period (2012 to 2023; up to 12 years)
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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)
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Prevalence of UC by Age-Stratified Groups
時間枠：During the index period (2012 to 2023; up to 12 years)
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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)
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Percentage of Participants Whose Primary Diagnosis Switched Between CD and UC
時間枠：During the index period (2012 to 2023; up to 12 years)
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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)
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Initial Treatment Types by Age-Stratified Group
時間枠：From index date to follow-up (Up to 13 years)
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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)
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Subsequent Treatment Sequences by Age-Stratified Group
時間枠：From index date to follow-up (Up to 13 years)
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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)
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Cumulative Persistence Rates for Biologic Drugs
時間枠：From index date to follow-up (Up to 13 years)
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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)
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Time to Discontinuation
時間枠：From index date to follow-up (Up to 13 years)
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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)
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Number of Hospitalizations
時間枠：From index date to follow-up (Up to 13 years)
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Number of hospitalizations both overall and by age groups will be reported. |
From index date to follow-up (Up to 13 years)
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Length of Hospitalization
時間枠：From index date to follow-up (Up to 13 years)
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Length of hospitalization both overall and by age groups will be reported. |
From index date to follow-up (Up to 13 years)
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Number of Emergency Department (ED) Visit
時間枠：From index date to follow-up (Up to 13 years)
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Number of ED visits both overall and by age groups will be reported. |
From index date to follow-up (Up to 13 years)
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Number of Outpatient Visits
時間枠：From index date to follow-up (Up to 13 years)
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Number of outpatient visits both overall and by age groups will be reported. |
From index date to follow-up (Up to 13 years)
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Number of Inflammatory Bowel Disease (IBD) Related Surgeries
時間枠：From index date to follow-up (Up to 13 years)
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Number of IBD related surgeries both overall and by age groups will be reported. |
From index date to follow-up (Up to 13 years)
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Number of Inpatient and Outpatient Visits to Non-Gastroenterology (GI) Departments
時間枠：From index date to follow-up (Up to 13 years)
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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)
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Medical Costs
時間枠：From index date to follow-up (Up to 13 years)
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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)
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協力者と研究者
捜査官
- スタディディレクター：Janssen Korea, Ltd. Clinical Trial、Janssen Korea, Ltd.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。