OLE Study With Filgotinib in JIA
ConditionJuvenile Idiopathic Arthritis (JIA)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age8-18
SponsorAlfasigma S.p.A.
About this trial
This OLE study is designed to evaluate long-term safety, tolerability, and efficacy of filgotinib in patients with polyarticular or systemic juvenile idiopathic arthritis (pJIA-sJIA) who have completed the treatment period/prolonged treatment period of the parent studies and demonstrated clinical benefit defined as control of disease activity through improvement in signs and symptoms as per Investigator judgement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must have completed treatment with filgotinib in at least one parent study and achieved a clinical benefit at the end of the parent protocols
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 informed consent form and assent (if required per local regulation) as approved by the Independent Ethics Committee/ Institutional Review Board, prior to any protocol 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
Female subject of childbearing potential who is sexually active and at risk for pregnancy must agree to use contraception/preventive exposure measures as described in the clinical study protocol.
Disqualifiers
Development of any condition during the parent study that would preclude safe continuation
Pregnancy
Active infection that is clinically significant, as per Investigator's judgement
Subject with known hypersensitivity to the components of potential study therapy
Trial design
Design model
Single group
Treatments tested in this trial
Filgotinib
DrugInvestigational product (IP) will be provided as commercially developed film-coated tablets or age-appropriate film-coated tablets for use in pediatric subjects aged at least 8 years and needs to be taken orally once daily (q.d.) at approximately the same time every morning (with or without food)
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: FilgotinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline (Day 1) up to Week 78Secondary outcomes
1
Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time.
Time frame
Week 1, Week 26, Week 52 and Week 782
Percentage of subjects with JIA ACR inactive disease.
Time frame
Week 1, Week 26, Week 52 and Week 783
Percentage of subjects with JIA ACR clinical remission over time.
Time frame
Week 1, Week 26, Week 52 and Week 784
Incidence of treatment-emergent uveitis (including severity).
Time frame
Week 1, Week 26, Week 52, Week 78Sponsors and contacts
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Source ClinicalTrials.gov