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
Qualifiers
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
Treatments tested in this trial
- Filgotinib
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov