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

Study Identifier
P15-619
CT.gov Identifier
NCT02578238
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol and Statistical Analysis Plan
Available Language(s): English
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    6 - 17 Years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

    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.

    Study Locations

    No locations found.