A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 86
- 主要终点
- Time to Disease Flare
研究概览
简要总结
The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have had a diagnosis of active JIA (polyarticular, extended oligoarticular, or enthesitis-related juvenile idiopathic arthritis [ERA] including JPsA).
- •Participants must have had an inadequate response to at least one conventional or biologic disease-modifying antirheumatic drug (DMARD).
排除标准
- •Participants must not have systemic JIA, with or without active systemic features.
- •Participants must not have persistent oligoarticular arthritis.
- •Participants must not have been previously treated with a Janus kinase (JAK) inhibitor.
研究组 & 干预措施
Baricitinib
Baricitinib was administered QD (once daily) as a 4-mg oral tablet for adolescent participants (12 to <18 years of age) and children ≥9 years of age; and 2 mg for children <9 years of age. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years old had the option of receiving an oral suspension. Participants >12 years old were supplied tablets. The oral suspension dose was administered as 4-mg, 2-mg, 1-mg, and 0.5-mg as needed.
干预措施: Baricitinib (Drug)
Placebo
Placebo matched to baricitinib was administered to participants during the DBW period.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Disease Flare
时间窗: Week 12 to Week 44
A disease flare is defined as a worsening of 30% or more in at least three of the six core Paediatric American College of Rheumatology (PedACR) criteria for juvenile rheumatoid arthritis (JIA) and an improvement of 30% or more in no more than one of the criteria. The six PedACR criteria are: 1) the number of active joints, 2) the number of joints with limited range of motion, 3) physician's global assessment of disease activity, 4) parent's global assessment of the participant's overall well-being, 5) physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ) and 6) acute-phase reactant (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]), the ESR measure is only used as an acute phase reactant in the core criteria.
次要结局
- Percentage of Participants Achieving PedACR30 Responder Index(Week 16, 20, 24, 28, 32, 36, 40 and 44)
- Percentage of Participants in Remission(Week 28, 32, 36, 40 and 44)
- Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score(Baseline, Week 44)
- Percentage of Participants Achieving PedACR90 Responder Index(Week 16, 20, 24, 28, 32, 36, 40 and 44)
- Percentage of Participants With Minimal Disease Activity(Week 16, 20, 24, 28, 32, 36, 40 and 44)
- Percentage of Participants With Inactive Disease(Week 16, 20, 24, 28, 32, 36, 40 and 44)
- Number of Participants With Change of Immunoglobulin G (IgG) Titers(Pre-Vaccination to 4 and 12 Weeks Post-Vaccination)
- Percentage of Participants Achieving PedACR50 Responder Index(Week 16, 20, 24, 28, 32, 36, 40 and 44)
- PK: Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss)(For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose))
- Percentage of Participants Achieving PedACR70 Responder Index(Week 16, 20, 24, 28, 32, 36, 40 and 44)
- Percentage of Participants Achieving PedACR100 Responder Index(Week 16, 20, 24, 28, 32, 36, 40 and 44)
- Change From Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item(Baseline, Week 44)
- Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)(For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose))
- Number of Participants With Product Acceptability and Palatability Assessment(Baseline and week 12)
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Score(Baseline, Week 44)
- Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index(Baseline, Week 44)
- Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index(Baseline, Week 44)
- Change From Baseline in Immunoglobulin Levels(Baseline, Week 12)