NCT04088396进行中（未招募）3 期
Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 105
- 主要终点
- Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12
研究概览
简要总结
The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.
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
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years
- •Participants must have at least 2 active joints at screening and baseline
- •Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age
- •Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age
排除标准
- •Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis
- •Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria
- •Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA
- •Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis
- •Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study
- •Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks
- •Participants must not have a current or recent (<4 weeks prior to baseline) clinically serious infection
- •Participants must not have a positive test for hepatitis B virus
- •Participants must not have evidence of active tuberculosis (TB) or untreated latent TB
研究组 & 干预措施
Cohort 1 Baricitinib
Experimental
Baricitinib given orally.
干预措施: Baricitinib (Drug)
Cohort 1 Tocilizumab
Active Comparator
Tocilizumab given Subcutaneously (SC).
干预措施: Tocilizumab (Drug)
Cohort 2 Baricitinib
Experimental
Baricitinib given orally.
干预措施: Baricitinib (Drug)
结局指标
主要结局
Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12
时间窗: Week 12
Percentage of Participants Achieving Adapted PediACR30 Response Criteria
次要结局
- Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24(Week 24)
- 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 24)
- Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)(Baseline through Week 24)
- PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss)(Baseline through Week 24)
- Percentage of Participants with Inactive Disease(Week 12)
- Percentage of Participants with Minimal Disease Activity(Week 12)
- Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27(Baseline, Week 24)
研究者
研究点 (105)
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