JPRN-jRCT2080221561未知3 期
A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agents
ovartis Pharma K.K.0 个研究点开始时间: 2011年9月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
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
- •Presence of RA classified by American College of Rheumatology (ACR) 2010 revised criteria for at least 3 months before screening
- •-Patients must have been taking at least one anti-TNF-alpha agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-alpha agent
排除标准
- •-Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician RA patients functional status class IV according to the ACR 1991 revised criteria
- •-Patients who have ever received biologic immunomodulating agents except for those targeting TNF-alpha
- •- Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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