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).
Phase 3 – large-scale trial before approval
Conditions:
Juvenile idiopathic arthritis
Sponsor: Alfasigma S.p.A.
trial.available_in:
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Overview
Trial status: Authorised
Percentage of subjects with JIA American College of Rheumatology (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.
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.
Description
Percentage of subjects with JIA American College of Rheumatology (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.
Who can participate
Age group: 0-17 years
Gender: Female, Male
Target enrollment: 18 participants
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