An Observational Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Pediatric Participants With Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Study Identifier
P20-379
CT.gov Identifier
NCT05411211
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 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Male or female participants aged 2-17 years old with body weight ≥ 10kg. * Diagnosis of polyarticular pJIA by treating physician. * Adalimumab (Humira®) treatment is indicated as per Chinese label and according to judgement of the physician to Chinese clinical practice guidelines for the diagnosis and treatment of juvenile idiopathic arthritis. * Participants or their parents/legal guardians are able and willing to give assent as well as informed consent approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) if applicable according to local law, and to comply with the requirements of this study protocol and Adalimumab (Humira ®) label.
    Exclusion Criteria:
    * Participants who cannot be treated with adalimumab according to Chinese Humira® label and by judgement of treating physician. * Participants who receive any biological disease-modifying anti-rheumatic drugs (bDMARDs) within 6 months prior to the screening visit or who are on concomitant use of any bDMARD. * Post menarche adolescent female subjects who are pregnant or breastfeeding or considering becoming pregnant during the study * Participant is considered by the investigator or sub-investigator, for any reason, to be an unsuitable candidate for the study.

    Protocol Summary

    Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease affecting children, characterized by chronic synovitis with systemic multi-organ damage. Polyarticular juvenile idiopathic arthritis (pJIA) is a subtype of JIA defined as disease involving more than five joints in the first 6 months of disease. This study will assess how safe and effective adalimumab (Humira®) is in treating pediatric participants with pJIA in China real-world setting.

    Adalimumab is an approved drug for the treatment of pJIA. Approximately 50 participants age 2 to 17 who are prescribed adalimumab for the treatment of pJIA in routine clinical practice will be enrolled at multiple sites in China.

    Participants will receive adalimumab per their physician's usual prescription. Individual data will be collected for 52 weeks.

    No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.

    Study Locations

    Location
    Status
    Location
    The Children's Hospital of Chongqing Medical University /ID# 232114
    Chongqing, Chongqing Municipality, China, 400065
    Status
    Not applicable
    Location
    Wuhan Children's Hospital /ID# 242274
    Wuhan, Hubei, China, 430000
    Status
    Not applicable