Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the New-Drug Re-examination

Study Overview
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Brief Summary
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This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be conducted in institutions which provide a written agreement to AbbVie Korea, and where the use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric patients who are prescribed Humira® as per physician's medical judgment in accordance with the approved Korean local label will be enrolled in the study. As this is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.

Official Title
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Post-Marketing Surveillance of Humira in Korean Pediatric CD Patients Under the New-Drug Re-examination

Conditions
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Pediatric Crohn's Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients with CD who are prescribed Humira in accordance with the Korean label for Humira authorization (labeling) Patients who have given written authorization to use their personal health data for the purposes of this study. Exclusion Criteria: Any contraindications to Humira as listed on the approved product market authorization (labeling) Patients who is participating on other clinical trials.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With Pediatric CD<br>Participants with pediatric CD who have been prescribed Humira® (adalimumab) by the treating physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs | An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with their treatment. If an AE meets any of the following criteria, it is considered a serious AE: results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, is an important medical event requiring medical or surgical intervention to prevent serious outcome. An ADR label was used for an AE when causal relationship with a pharmaceutical drug could not be excluded. | From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Korea, Humira, Pediatric Crohn's Disease