EUCTR2013-004002-25-ES进行中（未招募）1 期
A phase III, randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in autoinjectors, to demonstrate efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy up to 3 years in subjects with active Psoriatic Arthritis
ovartis Farmacéutica, S.A.0 个研究点目标入组 405 人开始时间: 2014年1月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 405
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
- •- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASification crietria for Psoriatic ARthritis (CASPAR) criteria
- •- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
- •- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis
- •- Inadequate control of symptoms with NSAID
- •Other protocol-definied inclusion criteria may apply
- •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 324
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 81
排除标准
- •- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
- •- Subjects taking high potency opioid analgesics
- •- Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
- •- Ongoing use of prohibited psoriasis treatments/medications
- •- Subjects who have ever received biologic immunomodulating agents except for those targeting TNF-alpha.
- •- Previous treatment with any cell-depleting therapies
- •Other protocol-definied exclusion criteria may apply
研究者
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