NCT06512337进行中（未招募）不适用
A Prospective Observational Study to Evaluate the Effectiveness of Deucravacitinib in Patients With Moderate Plaque Psoriasis in Real-World Settings in China (ADMIRE)
Bristol-Myers Squibb5 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2025年1月20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
- 进行中（未招募）
- 发起方
- 入组人数
- 153
- 试验地点
- 5
- 主要终点
- Number of participants achieving Static Physician's Global Assessment (sPGA) 0/1 score
研究概览
简要总结
The purpose of this study is to collect and evaluate real-world data on the effectiveness of deucravacitinib treatment in adults with moderate plaque psoriasis in China.
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
- •Participant aged 18 years or older
- •Physician-reported (dermatologist) diagnosis of moderate plaque psoriasis with Body Surface Area ≥ 3% and < 10%
- •Participant newly initiated deucravacitinib according to the label
- •Provided written informed consent to participate in the study
排除标准
- •Participating in or planning to participate in an interventional clinical trial
- •Concomitant use of other systemic treatments for psoriasis at baseline
- •Prior treatment of deucravacitinib
研究组 & 干预措施
Participants treated with deucravacitinib
Adults with moderate plaque psoriasis who are newly initiating deucravacitinib according to the product label
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Number of participants achieving Static Physician's Global Assessment (sPGA) 0/1 score
时间窗: Week 16
Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤ 3
时间窗: Week 16
Participant psoriasis Body Surface Area (BSA) involvement
时间窗: Week 16
次要结局
- Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 response and PASI 90 response(Baseline and Weeks 4, 12, 24, 36, and 52)
- Static Physician's Global Assessment (sPGA) 0/1 response at follow-up(Weeks 4, 12, 24, 36, and 52)
- Participants change in Static Physician's Global Assessment (sPGA) score from baseline(Baseline and Weeks 4, 12, 16, 24, 36, and 52)
- Number of participants achieving a Dermatology Life Quality Index (DLQI) 0/1 score(Baseline and Weeks 4, 12, 16, 24, 36, and 52)
- Number of participants achieving absolute Psoriasis Area and Severity Index (PASI) score ≤1, ≤2, ≤3, and ≤5(Baseline and Weeks 4, 12, 24, 36, and 52)
- Number of participants achieving psoriasis Body Surface Area (BSA) involvement of ≤1% and ≤3%(Baseline and Weeks 4, 12, 16, 24, 36, and 52)
- Change in Body Surface Area (BSA) involvement from baseline to follow-up(Weeks 4, 12, 24, 36, and 52)
- Number of participants achieving a Dermatology Life Quality Index (DLQI) ≤ 3 score(Baseline and Weeks 4, 12, 16, 24, 36, and 52)
- Participants change in Participant Absolute Psoriasis Area and Severity Index (PASI) score from baseline(Weeks 4, 12, 16, 24, 36, and 52)
- Change in participant Dermatology Life Quality Index (DLQI) score from baseline(Baseline and Weeks 4, 12, 16, 24, 36, and 52)
研究者
研究点 (5)
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