EUCTR2014-003849-10-SE进行中（未招募）1 期
A phase III, randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab (150 mg) in pre-filled syringe, with or without loading regimen, to demonstrate efficacy, safety and tolerability up to 2 years in patients with active psoriatic arthritis (FUTURE 4) - FUTURE 4
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 318
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 ClASsification criteria 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 protocoldefined inclusion criteria do 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 298
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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 TNFa.
- •Previous treatment with any cell-depleting therapies
- •Other protocol-defined exclusion criteria do apply
研究者
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