NL-OMON43926已完成3 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 (CAIN457F2310) - CAIN457F2310
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 20
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-lactating female patients at least 18 years of age.
- •* Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS.
- •* Patients should have been on NSAIDs with an inadequate response.
- •* Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose for at least 2 weeks.
- •* Patients who have been on an anti-TNF* agent (not more than one) must have experienced an inadequate response.
排除标准
- •* Chest X-ray with evidence of ongoing infectious or malignant process.
- •* Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17-receptor.
- •* Patients previously treated with any biological immunomodulating agents except for those targeting TNF*
- •* Previous treatment with any cell-depleting therapies
研究者
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