NCT03389984已完成不适用
Characterization of the Initial Psoriatic Skin Transcriptionnl Profile Associated to a Response to Adalimumab Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Change from baseline messenger ribonucleic acid expression at 16 weeks of treatment
研究概览
简要总结
The objective is to compare the initial skin inflammatory transcriptomic profile of psoriatic patient responder to Adalimumab therapy (defined as the achievement of a Psoriasis Area and Severity Index 75 response at 16 weeks) with the transcriptomic profile of patient non-responder to Adalimumab therapy (defined as the non-achievement of a Psoriasis Area and Severity Index 50 response at 16 weeks) to identify differentially expressed genes in order to define predictive markers of response to the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic plaque psoriasis involving at least 10% of body surface area, with a PASI score >10,
- •Negative pregnancy test for women of childbearing potential, and use of an effective method of contraception,
- •Pretreatment assessment to identify contraindications to anti-tumor necrosis factor-alpha therapy (chest x-ray and Intradermal reaction (detection of latent tuberculosis),
- •Anti-tumor necrosis factor-alpha treatment with adalimumab has been prescribed
排除标准
- •Classical exclusion criteria for adalimumab therapy (hypersensitivity to the product, severe heart failure, abscess, tuberculosis or other opportunistic infection),
- •History of demyelinating disease, any unstable medical condition, patients with recurrent serious infections , history of cardiovascular or cerebrovascular disease , history of cancer
- •Patients not having tuberculosis prophylaxis as per local guidelines for latent tuberculosis, or patients non-treated active tuberculosis
- •Ongoing pregnancy or breastfeeding
- •Absence of written consent,
- •Prior treatment with one of the following anti-psoriatic treatments: biologics during the 3 months prior baseline visit, other systemic treatment during the 4 weeks prior baseline visit or topical therapy during the 2 weeks prior baseline visit.
结局指标
主要结局
Change from baseline messenger ribonucleic acid expression at 16 weeks of treatment
时间窗: From baseline to 16 weeks treatment
messenger ribonucleic acid expression assessed by quantitative reverse transcription-polymerase chain reaction
次要结局
- Change from baseline drug and anti-drug concentrations at 16 weeks of treatment(From baseline to 16 weeks treatment)
研究者
研究点 (2)
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