This is a multicenter Phase 3, open-label, single-arm study to evaluate the safety, tolerability, PK, and efficacy of orally administered filgotinib for up to 18 weeks.
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 ICF and assent (if required per local regulation) as approved by the Independent Ethics Committee / Institutional Review Board, prior to any screening evaluations.
Female or male subject 8 to <18 years of age, on the date of signing the informed consent and assent (per local regulation) form.
Extended oligoarthritis (i.e. affecting a total of more than 4 joints after the first 6 months of disease)
RF-positive polyarthritis
Subject with a body weight <15 kg.
Subject with persistent oligoarthritis (i.e. affecting not more than 4 joints throughout the disease course).
Subject with undifferentiated arthritis.
Subject with anterior uveitis (active or uncontrolled) ≤12 weeks prior to baseline.
Single group
Filgotinib
DrugIP will be provided as commercially developed film-coated tablets or age-appropriate film- coated tablets for use in paediatric subjects aged at least 8 years and needs to be taken orally q.d. at approximately the same time every morning (with or without food)
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation
Percentage of subjects with juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 30 response
Percentage of subjects with JIA ACR inactive disease
Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 erythrocyte sedimentation rate (ESR)
Change from baseline in Juvenile Arthritis Disease Activity Score JADAS-27 C-reactive protein (CRP)
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