Status:
COMPLETED
An Observational Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Pediatric Participants With Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Lead Sponsor:
AbbVie
Conditions:
Polyarticular Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-17 years
Brief 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 arth...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 8 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05411211
Start Date
November 10 2022
End Date
September 8 2024
Last Update
March 24 2025
Active Locations (2)
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1
The Children's Hospital of Chongqing Medical University /ID# 232114
Chongqing, Chongqing Municipality, China, 400065
2
Wuhan Children's Hospital /ID# 242274
Wuhan, Hubei, China, 430000