[M15-340]A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

JRCT ID: jRCT2031220577

Registered date:18/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Polyarticular Course Juvenile Idiopathic Arthritis
• Date of first enrollment: 23/03/2023
• Target sample size: 124
• Countries of recruitment: Germany,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Puerto Rico,Japan,Spain,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

- Participants of age group 12 to <18 years administered with upadacitinib dose A (weight dependent)
- Participants of age group 12 to <18 years administered with upadacitinib dose B (weight dependent)
- Participants of age group 6 to <12 years administered with upadacitinib dose A (weight dependent)
- Participants of age group 2 to <6 years administered with upadacitinib dose A (weight dependent)
- Participants of age group 2 to <18 years administered with upadacitinib dose A

Outcome(s)

• Primary Outcome: Treatment Emergent Adverse Events (TEAEs)

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 17age old
• Gender: Both

Include 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 during the first 6 months of disease (for extended oligoarticular JIA: <=4 joints during 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 10 to 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 10mg/day or 0.2mg/kg/day, whatever is lower) for at least 1 week before and including Study Day 1.

Exclude criteria

- Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
- Participant have prior exposure to JAK inhibitor.

Related Information

• Primary Sponsor: Yamazaki Hayato
• Secondary ID(s): NCT03725007