EUCTR2012-000046-35-ES进行中（未招募）1 期
A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis
ovartis Farmacéutica, S.A.0 个研究点目标入组 222 人开始时间: 2012年9月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 222
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
- •1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
- •2. Male or non-pregnant, non-lactating female patients at least 18 years of age.
- •3. Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist?s report) fulfilling the Modified New York criteria for AS (Appendix 3) with active AS assessed by BASDAI ?4 (0-10) and spinal pain as measured by VAS?4 cm at Baseline.
- •4. Patients should have been on NSAIDs at the highest recommended dose for at least 3 months prior to randomization with an inadequate response or failure to respond, or less
- •than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications.
- •5. Patients who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable dose for at least 2 weeks before randomisation.
- •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 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Chest x-ray or MRI with evidence of ongoing infectious or malignant process, obtained within 3 months of screening and evaluated by a qualified physician.
- •2. Patients with total ankylosis of the spine.
- •3. Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine)
- •4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor.
- •Other protocol-defined exclusion criteria may apply.
研究者
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