EUCTR2015-001106-33-ES进行中（未招募）1 期
A randomized, double-blind, placebo-controlled multicenter study of secukinumab to evaluate the safety, tolerability and efficacy up to 2 years in patients with active non-radiographic axial spondyloarthritis
ovartis Farmacéutica S.A.0 个研究点目标入组 555 人开始时间: 2016年2月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 n.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 TNF alpha inhibitor (not more than one) must have experienced an inadequate response
- •- 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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