NCT07256015招募中不适用
"DEMOS" - Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年8月5日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The percentage of participants still receiving deucravacitinib treatment
研究概览
简要总结
The purpose of this study is to characterize the real-life experience of patients with moderate/severe psoriasis receiving deucravacitinib treatment, in terms of efficacy, safety, and health-related quality of life (HRQoL) in Italy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants have initiated treatment with deucravacitinib monotherapy 4 to 8 weeks earlier according to clinical practice and to reimbursement criteria determined by National Drug Agency in Italy (AIFA)
- •Patients have moderate to severe plaque psoriasis
- •Patients have signed informed consent form (ICF)
排除标准
- •Simultaneous participation in any interventional study for their moderate-to-severe psoriasis
- •Inability to participate to the study for the following reasons: patients unable to understand the aim of the study, patients unable to understand and sign the ICF
研究组 & 干预措施
Cohort 1
Participants with moderate/severe psoriasis receiving deucravacitinib
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
The percentage of participants still receiving deucravacitinib treatment
时间窗: Week 24 and 52
Absolute Psoriasis Area and Severity Index (PASI)
时间窗: Baseline and Weeks 16, 24 and 52
次要结局
- Participant age in years(Baseline)
- Participant sex(Baseline)
- Participant height in cm(Baseline)
- Participant body mass index in kg/m2(Baseline)
- Participant previous pathologies(Baseline)
- Participan previous surgical procedures(Baseline)
- Date of psoriasis diagnosis(Baseline)
- Number of participants with physical examination according to body systems(Baseline)
- Participant treatment history(Baseline)
- Participant comorbidities(Baseline)
- Quality of life as assessed by the Dermatology Life Quality Index (DLQI) questionnaire(Baseline and Weeks 16, 24 and 52)
- Change in symptoms as assessed by the Itch Numerical Rating Scale (Itch-NRS) score(Baseline and Weeks 16, 24 and 52)
- Body Surface Area (BSA)(Baseline and Weeks 16, 24 and 52)
- Static Physician's Global Assessment (sPGA) score(Baseline and Weeks 16, 24 and 52)
- Scalp Specific Physician Global Assessment (ssPGA) score(Baseline and Weeks 16, 24 and 52)
- Scalp Specific Physician Global Assessment (ssPGA) score 0/1(Baseline and Weeks 16, 24 and 52)
- Absolute Psoriasis Area and Severity Index (PASI) 75 and 90(Baseline and Weeks 16, 24 and 52)
- Concomitant psoriasis therapies received(Baseline and Weeks 16, 24 and 52)
研究者
研究点 (1)
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