A Study to Assess Persistence, Adherence and Changes in Disease Activity in the Children Population of Juvenile Arthritis Patients Treated With Adalimumab (HUMIRA®)

Study Identifier
P17-164
CT.gov Identifier
NCT03383263
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
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Study Details

Medical Condition
  • Juvenile Idiopathic Arthritis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    2 - 18 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Confirmed diagnosis of polyarticular Juvenile Idiopathic Arthritis (JIA) according to International League of Associations for Rheumatology (ILAR) criteria . * Planned treatment with HUMIRA according to the local product label and prescription guidelines. Alternatively, subjects assigned to HUMIRA treatment not more than 1 month prior to inclusion can be enrolled. * Negative result of tuberculosis (TB) screening procedure and TB specialist permission to start biologic therapy. * Patient's informed consent form signed by the parent or guardian/and by the child, if applicable.
    Exclusion Criteria:
    * Has contraindications for the treatment with HUMIRA according to the latest version of the locally approved label. * Any biologic drugs taken prior to 3 months of enrolment in the study. * Patients treated with any biosimilar version of HUMIRA * Previous participation and dropout from this study. * Patients participating in another clinical and/or observational study priory 3 months before the enrolment to this study.

    Protocol Summary

    The objective of this study is to assess persistence, adherence and changes in disease activity in the children population of juvenile arthritis patients treated with adalimumab (HUMIRA®) in the routine clinical settings in the Russian Federation.

    Study Locations

    Location
    Status
    Location
    Republican Children's Clinical Hospital /ID# 204830
    Ufa, Bashkortostan Republic, Russian Federation, 450106
    Status
    Not applicable
    Location
    Chelyabinsk Regional Children's Clinical Hospital /ID# 204829
    Chelyabinsk, Chelyabinsk Oblast, Russian Federation, 454087
    Status
    Not applicable
    Location
    Saratov State Medical University n.a. V.I. Razumovskiy /ID# 206319
    Saratov, Saratov Oblast, Russian Federation, 410012
    Status
    Not applicable
    Location
    Kazan State Medical Academy /ID# 207004
    Kazan', Russian Federation, 420012
    Status
    Not applicable
    Location
    Morozovskaya Children's City Clinical Hospital /ID# 207006
    Moscow, Russian Federation, 119049
    Status
    Not applicable
    Location
    Sechenov First Moscow Medical /ID# 207005
    Moscow, Russian Federation, 119992
    Status
    Not applicable
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