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Recruiting
NCT07553182
OLE Study With Filgotinib in JIA
Conditions: Juvenile Idiopathic Arthritis (JIA)
Sex: All
Ages: 8 Years – 18 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 80
Sponsor: Alfasigma S.p.A.
Location: Bicetre Hospital Le Kremlin-Bicêtre
Summary
This OLE study is designed to evaluate long-term safety, tolerability, and efficacy of filgotinib in patients with polyarticular or systemic juvenile idiopathic arthritis (pJIA-sJIA) who have completed the treatment period/prolonged treatment period of the parent studies and demonstrated clinical benefit defined as control of disease activity through improvement in signs and symptoms as per Investigator judgement.
Eligibility Criteria
Inclusion Criteria:
* Subject must have completed treatment with filgotinib in at least one parent study and achieved a clinical benefit at the end of the parent protocols
* Subject and/or parent/legal guardian must be able and willing to comply with the clinical study protocol requirements and must sign and date the informed consent form and assent (if required per local regulation) as approved by the Independent Ethics Committee/ Institutional Review Board, prior to any protocol evaluations
* Female or male subject 8 to \
Source: ClinicalTrials.gov (NCT07553182). StuddyBuddy aggregates publicly available trial information.