An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Polyarticular Course Juvenile Idiopathic Arthritis
概览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 10
- 主要终点
- The values for the pharmacokinetic parameters of upadacitinib including Cmax, time to maximum observed plasma concentration (Tmax), area under the plasma concentration versus time curve during a dosing interval (AUCtau) on Day 7, and apparent oral clearance at steady state (CL/F) will be determined using non-compartmental methods.
概览
简要总结
To evaluate the pharmacokinetics, safety, and tolerability of multiple doses of upadacitinib in pediatric subjects with pcJIA. To evaluate the long-term safety and tolerability of multiple doses of upadacitinib in pediatric subjects with pcJIA who completed part 1. To evaluate the long-term safety and tolerability of upadacitinib in pediatric subjects with pcJIA. To evaluate descriptive efficacy of upadaciinib in pcJIA.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- 156 Week Study To Evaluate The Palatability Of Upadacitinib In Pediatric Subjects.
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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
- •No prior exposure to JAK inhibitor.
排除标准
- •Subject must have a diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
- •Prior exposure to JAK inhibitor.
结局指标
主要结局
The values for the pharmacokinetic parameters of upadacitinib including Cmax, time to maximum observed plasma concentration (Tmax), area under the plasma concentration versus time curve during a dosing interval (AUCtau) on Day 7, and apparent oral clearance at steady state (CL/F) will be determined using non-compartmental methods.
The values for the pharmacokinetic parameters of upadacitinib including Cmax, time to maximum observed plasma concentration (Tmax), area under the plasma concentration versus time curve during a dosing interval (AUCtau) on Day 7, and apparent oral clearance at steady state (CL/F) will be determined using non-compartmental methods.
次要结局
- To evaluate the palatability of upadacitinib oral solution in pediatric subjects.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG