CTRI/2021/04/032948招募中3 期
A Phase 3 Multicenter Study to Evaluate the Long-Term Safety andEfficacy of Baricitinib in Patients from 1 Year to 18 Years of Age with JuvenileIdiopathic Arthritis (JIA)
Eli Lilly and Company India Pvt Ltd4 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2021年4月23日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 410
- 试验地点
- 4
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs)
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 the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants must have completed a previous study of baricitinib for the treatment of JIA.
排除标准
- •Participants must not have had a permanent discontinuation of baricitinib in the prior study.
- •Participants must have not developed an allergy to baricitinib.
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
时间窗: Baseline through Week 264
次要结局
- Proportion of Participants with Inactive Disease(Week 264)
- Proportion of Participants with Minimal Disease Activity(Week 264)
- Proportion of Participants in Remission(Week 264)
- Proportion of Participants who have Disease Flare(Baseline through Week 264)
- Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)(Week 264)
- Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)(Baseline, Week 264)
- 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 264)
- Change from Baseline in Psoriasis Area and Severity Index (PASI)(Baseline, Week 264)
- Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index(Baseline, Week 264)
- Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)(Baseline, Week 264)
- Change from Baseline in Immunoglobulin Levels(Baseline, Week 264)
- Change from Baseline in Immunophenotyping (T Cells)(Baseline, Week 264)
- Change of Immunoglobulin G (IgG) Titers(Pre-Vaccination to 12 Weeks Post-Vaccination)
研究者
研究点 (4)
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