JPRN-jRCT2080222045未知3 期
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents
ovartis Pharma K.K.0 个研究点目标入组 234 人开始时间: 2013年3月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 234
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 Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months
- •Disease activity defined by >=6 tender joints out of 68 and >=6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR Rheumatoid Factor positive AND WITH Either hsCRP >=10 mg/L OR ESR >=28 mm/1st hr
- •Intake of at least one anti-TNFalpha agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab for at least 3 months before entering the study and to have experienced an inadequate response to treatment or to have been intolerant to at least one administration
排除标准
- •Current RA functional status class IV according to the ACR 1991 revised criteria
- •Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
- •Any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes
- •Other protocol-defined inclusion/exclusion criteria may apply
研究者
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