Juvenile Idiopathic Arthritis (JIA)
Conditions
Brief summary
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.
Interventions
DRUGFilgotinib
Investigational 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)
Sponsors
Alfasigma S.p.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Subjects with any condition or circumstances (including abnormalities in laboratory parameters) that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | From baseline (Day 1) up to Week 78 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time. | Week 1, Week 26, Week 52 and Week 78 |
| Percentage of subjects with JIA ACR inactive disease. | Week 1, Week 26, Week 52 and Week 78 |
| Percentage of subjects with JIA ACR clinical remission over time. | Week 1, Week 26, Week 52 and Week 78 |
| Incidence of treatment-emergent uveitis (including severity). | Week 1, Week 26, Week 52, Week 78 |
Countries
France, Germany, United Kingdom
Contacts
CONTACTCatherine Vincent
Outcome results
None listed