Multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of filgotinib in children and adolescents from 8 years to less than 18 years of age with polyarticular-course juvenile idiopathic arthritis

Polyarticular-course juvenile idiopathic arthritis

Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation (up to approximately Week 22 or throughout the duration of the study)

− Percentage of subjects with juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) 30 response at Week 12 and Week 18 − Percentage of subjects with JIA ACR inactive disease at Week 12 and Week 18 − Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 erythrocyte sedimentation rate (ESR) and JADAS-27 C-reactive protein (CRP) at Week 12 and Week 18, Incidence of uveitis at various timepoints (including occurrence, type, and severity), PK parameters of filgotinib and its primary metabolite GS-829845 (including maximum observed plasma concentration at steady-state [Cmax,ss], area under the plasma concentration-time curve over the dosing interval at steady-state [AUC0-24,ss], and area under the plasma concentration-time curve over the dosing interval at steady-state for the effective exposure [AUCeff,ss]), Acceptability of the age-appropriate pediatric formulation and the adult commercially developed film-coated tablet formulation assessed by Pediatric Oral Medicine Acceptability Questionnaire for Patients (POMAQ-P)

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