NCT06701513招募中不适用
Registry of Psoriasis Health Outcomes: A Longitudinal Real-world Collaboration (RePhlect) - A Real-world, Prospective, Observational Study of the Effectiveness of Deucravacitinib in Adults With Moderate-to-Severe Plaque Psoriasis in France
Bristol-Myers Squibb73 个研究点 分布在 2 个国家目标入组 350 人开始时间: 2025年1月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 73
- 主要终点
- Physician's Global Assessment (PGA) 0/1 response
研究概览
简要总结
The purpose of this study is to assess the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis
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
- •≥18 years of age
- •Physician-reported diagnosis of moderate to severe plaque psoriasis
- •Be newly initiating deucravacitinib
- •Do not object to participate
排除标准
- •Currently participating in or planning to participate in an interventional clinical trial
- •Previous treatment experience with deucravacitinib, including patients who received deucravacitinib as part of a blinded, randomized trial
研究组 & 干预措施
Participants that have initiated deucravacitinib treatment
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Physician's Global Assessment (PGA) 0/1 response
时间窗: Baseline and at months 4, 12, 18 (optional), and 24
Dermatology Life Quality Index (DLQI) 0/1 response
时间窗: Baseline and at months 4, 12, 18 (optional), and 24
Time from date of treatment initiation to date of discontinuation
时间窗: Up to 24 months
次要结局
- Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS)] - Fatigue(Baseline and months 1, 4, 12, 18 (optional) and 24)
- Physician's Global Assessment (PGA) score change from start of deucravacitinib treatment to follow-up(Baseline and at months 4, 12, 18 (optional), and 24)
- Change in percentage involved Body Surface Area (BSA) from start of deucravacitinib treatment(Baseline and at months 4, 12, 18 (optional), and 24)
- Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Itch(Baseline and months 1, 4, 12, 18 (optional) and 24)
- Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Skin pain(Baseline and months 1, 4, 12, 18 (optional) and 24)
- Dermatology Life Quality Index (DLQI) score of ≤5(Baseline and at months 1, 4, 12 18 (optional) and 24)
- Body Surface Area (BSA) of ≤ 3%(Baseline and at months 4, 12, 18 (optional), and 24)
- Body Surface Area (BSA) of ≤ 1%(Baseline and at months 4, 12, 18 (optional), and 24)
- Reasons for deucravacitinib treatment discontinuation(Up to 24 months)
研究者
研究点 (73)
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