A Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing Spondylitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16
研究概览
简要总结
This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor
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
- •Male or non-pregnant, non-lactating female patients
- •Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS (1984)
- •Patients should have been on NSAIDs with an inadequate response
- •Patients who were regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose
- •Patients who had been on an anti-TNFα agent (not more than one) must have experienced an inadequate response
排除标准
- •Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process
- •Patients with total ankylosis of the spine
- •Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
- •Previous treatment with any cell-depleting therapies
研究组 & 干预措施
Secukinumab 75 mg
Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
干预措施: Secukinumab (75 mg) (Drug)
Secukinumab 150 mg
Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
干预措施: Secukinumab (150 mg) (Drug)
Placebo
Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16
时间窗: Baseline up to 16 weeks
ASAS 20 response is a validated composite assessment reflecting the percentage of treated patients who achieve within a defined timeframe an improvement of 20% and ≥1 unit on a scale of 1 to 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.
次要结局
- Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response(Baseline up to 16 weeks)
- Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)(Baseline up to 16 weeks)
- Change From Baseline at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline up to 16 weeks)
- Percentage of Participants Achieving ASAS Partial Remission at Week 16(Baseline up to 16 weeks)
- Change From Baseline at Week 16 in Serum hsCRP(Baseline up to 16 weeks)
- Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16(Baseline up to 16 weeks)
- Change From Baseline at Week 16 in ASQoL(Baseline up to 16 weeks)