An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Polyarticular Course Juvenile Idiopathic Arthritis (Poly JIA)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AE) of Interest
研究概览
简要总结
Primary Objective of the study:
the purpose of this extension study was to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit at least pediACR30 response);
详细描述
Givinostat is expected to exert a clinically relevant therapeutic effect on polyarticular JIA through the inhibition of the production/release of pro-inflammatory cytokines, such as IL-1β, IL-6 and TNFα, which are involved in the pathogenesis of the arthritic process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects who had successfully completed the previous Dose Finding Study and were fully compliant to the inclusion/exclusion criteria described in the previous DSC/08/2357/36
排除标准
- •patients with fever related to JIA or other systemic features of JIA during 12 months before entering the study
- •active bacterial or mycotic infection requiring antimicrobial treatment
- •episode of macrophage activation syndrome over the last 6 months
- •baseline prolongation of QT/QTc interval, use of concomitant medications that prolong the QT/QTc interval or history of additional risk factors for TdP.
- •clinically significant cardiovascular disease
- •clinically significant illness i.e. any condition that in the opinion of the Investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
- •psychiatric illness/social situation that would limit compliance with study medication and protocol requirements
- •inherited metabolic diseases
- •presence of malignancy
- •pregnancy or lactation
- •positive blood test for HIV
- •active EBV infection, active B and/or C hepatitis
- •platelet count <100x10(9)/L
研究组 & 干预措施
Givinostat
Patient received the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014
干预措施: Givinostat (Drug)
结局指标
主要结局
Number of Participants With Serious Adverse Events (SAE) and Adverse Events (AE) of Interest
时间窗: Through end of treatment, up to 108 weeks.
During the entire study period it was reported only one adverse event considered not drug related by the investigator (Mild flu at week 107 of study treatment). No action was taken and the patient recovered spontaneously
次要结局
- Number of Patients Who Reached PedACR70 Response(At weeks 48, 60 and 108)
- Number of Patients Who Maintained PedACR30 Response(At weeks 48, 60 and 108)