EUCTR2015-001106-33-SE进行中（未招募）1 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 - PREVENT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 555
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or non-pregnant, non-nursing female patients at least 18 years of age
- •Diagnosis of axSpA according to ASAS axSpA criteria
- •Objective signs of inflammation (MRI or abnormal CRP)
- •Active axSpA as assessed by total BASDAI >=4 cm
- •Spinal pain as measured by BASDAI question #2 = 4 cm (0-10 cm) at baseline
- •Total back pain as measured by VAS = 40 mm (0-100 mm) at baseline
- •Patients should have been on at least 2 different NSAIDs with an inadequate response
- •Patients who have been on a TNFa inhibitor (not more than one) must have experienced an inadequate response
- •For the extension phase of the study:
- •Patients who have completed the full study treatment period (104 weeks) in the core phase on study treatment
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 505
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
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 IL-17 or IL-17 receptor
- •Pregnant or nursing (lactating) women
- •Other protocol-defined exclusion criteria may apply
研究者
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