EUCTR2012-002760-27-ES进行中（未招募）不适用
A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis
ovartis Farmaceutica, S.A.0 个研究点目标入组 345 人开始时间: 2013年1月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 345
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) Subjects who provide a written, signed and dated informed consent before any study assessment is performed
- •2) Subjects must have participated in phase III study CAIN457F2309, must have completed the entire treatment period and must have received secukinumab during phase III study (either from start of phase III study or after re-assignment to one of the secukinumab arms after week 16/24)
- •3) Subjects who are deemed by the investigator to benefit from continued secukinumab therapy
- •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 276
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 69
排除标准
- •1) Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
- •2) Any subject who is deemed not to be benefiting from the study drug based upon lack of improvement or worsening of their symptoms
- •3) Any subject who continued to receive abatacept after week 16 during the phase III study CAIN457F2309
- •Other protocol-defined exclusion criteria may apply
研究者
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