An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis - M15-340

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 124 人开始时间: 2023年6月19日最近更新: 2024年8月21日

适应症

试验速览

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•Individuals, ages 2 to less than 18 years, and total body weight of 10 kg or higher at the time of Screening., 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 arthritis affecting at least 5 joints within the first 6 months of disease (for extended oligoarticular JIA: = 4 joints within the first 6 months of disease and > 4 joints thereafter)., Subject must not have a diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA)., 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 limitation of movement (LOM) plus pain on motion and/or tenderness with palpation, 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, subjects should take either folic acid or folinic acid according to local standard of care, If on oral glucocorticoids, must have been taking oral glucocorticoids 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., No prior exposure to JAK inhibitor.

•Subject must have a diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA)., Prior exposure to JAK inhibitor.

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