SELECT-YOUTH
Brief summary
This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of three parts: Part 1 is multiple-cohort study that consists of two sequential multiple dose groups. Participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in Part 2. Part 2 is open-label, long term extension study to evaluate safety and tolerability. Part 3 is an additional safety cohort to evaluate long-term safety and tolerability.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 2 Years to 17 Years.
Inclusion Criteria:
- Participant have total body weight of 10 kg or higher at the time of screening.
- Participant diagnosed with pcJIA (rheumatoid factor-positive or rheumatoid
factor-negative polyarticular JIA, extended oligoarticular JIA, or systemic JIA with
active arthritis and without active systemic features) with a history of arthritis
affecting at least 5 joints within the first 6 months of disease (for extended
oligoarticular JIA: <=4 joints within first 6 months of disease and >4 joints
thereafter).
- Participant have 5 or more active joints at the time of screening, defined as the
presence of swollen joints (not due to deformity) or, in the absence of swelling,
joints with the limitation of movement (LOM) plus pain on motion and/or tenderness
with palpitation, with LOM present in at least three of the active joints.
- If receiving methotrexate (MTX), have been taking MTX for at least 12 weeks
immediately before and including Study Day 1 on a stable dose of <=20 mg/m2 for at
least 8 weeks before and including Study Day 1; in addition, participants should
take either folic acid or folinic acid according to local standard of care.
- If on oral glucocorticosteroids, must have been taking oral glucocorticosteroids at
a stable dose (no greater than 10 mg/day or 0.2 mg/kg/day, whatever is lower) for at
least 1 week before and including Study Day 1.
Exclusion Criteria:
- Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile
psoriatic arthritis (JPSA).
- Participant have prior exposure to JAK inhibitor.
