NL-OMON47618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 optimal phase of either 150 mg or 300 mg randomized dose escalation for up to another 2 years - CAIN457H2315 (PREVENT)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •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
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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