A Multicenter Uncontrolled Extension Study Evaluating the Long Term Safety and Efficacy of SAR153191 in Patients With Ankylosing Spondylitis (AS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Percentage of Participants Experiencing Any Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Treatment Discontinuation
研究概览
简要总结
Primary Objective:
- To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS)
Secondary Objective:
- To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS
详细描述
The maximum study duration per participant was to be 267 weeks (approximately 5 years) broken down as follows:
- screening up to a maximum of 1 week;
- treatment up to a maximum of 260 weeks;
- follow-up of 6 weeks after treatment discontinuation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sarilumab
Sarilumab 150 mg subcutaneous (SC) injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.
干预措施: Sarilumab (Drug)
结局指标
主要结局
Percentage of Participants Experiencing Any Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Treatment Discontinuation
时间窗: Baseline up to the end of study (66 weeks)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of the relationship to the investigational medicinal product (IMP). SAE was any untoward medical occurrence that at any dose resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the TEAE period (time from first dose of IMP up to the end of follow-up period).
次要结局
- Percentage of Participants Who Achieved 20% Response in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20)(Baseline up to the end of treatment (60 weeks))