NCT05633264已完成不适用
Deucravacitinib Post-marketing Surveillance in Patients With Psoriasis in Japan
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 369 人开始时间: 2022年12月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of deucravacitinib for the treatment of plaque psoriasis (PsO) in Japan participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Psoriasis (PsO) participants who received Deucravacitinib for the first time of the approved indications at medical institutions in Japan will be enrolled in this PMS
排除标准
- •Participants receiving Deucravacitinib for an off-label indication will be excluded from this PMS.
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Up to 52 weeks
次要结局
- Change from Baseline in Body Surface Area (BSA) during study period(Up to 52 weeks)
- Distribution of demographic characteristics: Age(Up to 52 weeks)
- Distribution of demographic characteristics: Height(Up to 52 weeks)
- Proportion of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period(Up to 52 weeks)
- Distribution of demographic characteristics: Sex(Up to 52 weeks)
- Distribution of demographic characteristics: Weight(Up to 52 weeks)
- Distribution of demographic characteristics: Past history /complication(Up to 52 weeks)
- Proportion of participants achieving Global Improvement Score (GIS) during study period(Up to 52 weeks)
研究者
研究点 (1)
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