JPRN-jRCT2080223186未知3 期
An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis
ovartis Pharma K.K.0 个研究点目标入组 30 人开始时间: 2016年4月27日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 30
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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 with active AS assessed by BASDAI >= 4 (0-10) and spinal pain as measured by VAS>= 4 cm (BASDAI question #2) at Baseline
- •-Patients should have been on NSAIDs at the highest recommended dose for at least 3 months prior to baseline with an inadequate response or failure to respond, or less than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications
- •-Patients who have been on a TNFalpha inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or have been intolerant to at least one administration of an anti-TNFalpha agent
排除标准
- •-Patients with total ankylosis of the spine
- •-Patients previously treated with any biological immunomodulating agents except for those targeting TNFalpha
- •-Active ongoing inflammatory diseases other than AS that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis
- •-Known infection with HIV, hepatitis B or hepatitis C at screening or baseline
研究者
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