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.