A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response
研究概览
简要总结
This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
干预措施: Secukinumab (75 mg) (Drug)
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
干预措施: Secukinumab (150 mg) (Drug)
Placebo
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response
时间窗: 16 weeks
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.
次要结局
- Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response(16 weeks)
- Assessment of Responders for ASAS Partial Remission(16 weeks)
- Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response(16 weeks)
- Change From Baseline in Serum hsCRP(Base line and Week 16)
- Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS(baseline, 16 weeks)
- Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL(baseline and 16 weeks)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI(Baseline and 16 weeks)