Open Label Extension (OLE), multiple dose study to evaluate pharmacokinetics, safety, tolerability and efficacy of filgotinib in children and adolescents from 8 years to less than 18 years of age with juvenile idiopathic arthritis (JIA).

Condition studied

Juvenile idiopathic arthritis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation at each visit throughout the duration of the study.

Endpoint detail

Percentage of subjects with JIA (ACR) 30 response over time., Percentage of subjects with JIA ACR inactive disease., Percentage of subjects with JIA ACR clinical remission over time., Incidence of treatment-emergent uveitis (including severity)., Duration of response.