jRCT2080223230已完成3 期
A randomized, double-blind, placebo-controlled multicenter study of secukinumab 150 mg in patients with active non-radiographic axial spondyloarthritis to evaluate the safety, tolerability and efficacy up to 2 years, followed by an optional phase of either 150 mg or 300 mg randomized dose escalation for up to another 2 years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- ASAS 40 response
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, Parallel Assignment, Double Blind Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or non-pregnant, non-nursing female patients at least 18 years of age
- •Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
- •objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
- •active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index >=4 cm
- •Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 >= 4 cm (0-10 cm) at baseline
- •Total back pain as measured by Visual Analogue scale >= 40 mm (0-100 mm) at baseline
- •Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
- •Patients who have been on a TNFalfa inhibitor (not more than one) must have experienced an inadequate response
排除标准
- •Patients with radiographic evidence for sacroiliitis, grade >= 2 bilaterally or grade >= 3 unilaterally
- •Inability or unwillingness to undergo MRI
- •Chest X-ray or MRI with evidence of ongoing infectious or malignant process
- •Patients taking high potency opioid analgesics
- •Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
- •Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
ASAS 40 response
时间窗: Week 16, 52
ASAS40 (Assessment of SpondyloArthritis International Society criteria) response is defined as an improvement of >=40% and >=2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain
次要结局
- The proportion of participants who achieved an ASAS 5/6(Week 16)
- Change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) over time(Week 16)
- Change in SF-36 (Short Form-36 Physical Component Summary) physical Component Summary over time(Week 16 and 52)
研究者
研究点 (1)
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