Surveillance of Humira in Korean JIA Patients

Study Identifier
P14-362
CT.gov Identifier
NCT02141984
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Juvenile Idiopathic Arthritis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    2+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Patients from 2 years of age who were diagnosed with polyarticular juvenile idiopathic arthritis (JIA) or patients from 6 years of age who were diagnosed with enthesitis-related arthritis (ERA). * Polyarticular juvenile idiopathic arthritis (JIA) patients for whom the response to previous disease-modifying anti rheumatic drug therapy has been inadequate * Patients who give written authorization form to use their personal and health data from legal parents or representative. * Physician will refer to the product market authorization (label) for inclusion criteria.
    Exclusion Criteria:
    * Patients with known hypersensitivity to Humira or any of its excipients. * Patients who is participating on other clinical trials. * Physician will refer to the product market authorization (label) for exclusion criteria.

    Protocol Summary

    Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, underlying diseases and complications especially in regard to purified protein derivative (PPD) skin test, and chest X-ray. At routine visits for Humira Injection administration, which will occur according to usual medical practice, concomitant medication information and adverse events information will be collected for up to 70 days after the last administration of Humira.

    Study Locations

    No locations found.