NCT05744466招募中不适用
A Real-world, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib Versus Apremilast in Adults With Plaque Psoriasis - North American Region
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2022年9月30日最近更新:
适应症
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
- 1,500
- 试验地点
- 1
- 主要终点
- Change in body surface area (BSA)
研究概览
简要总结
The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with 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
- •Have been diagnosed with plaque psoriasis by a dermatologist
- •Newly initiating an eligible medication for enrollment (i.e., deucravacitinib, apremilast)
- •Actively enrolled in the CorEvitas Psoriasis Registry and have documented consent to allow copies of information from the registry be used for research purposes
排除标准
- •Participation (current or planned) in an interventional clinical trial (does not include observational registry or study)
- •Restart of treatments with the study eligible therapies previously received at any time during the participants' treatment history
研究组 & 干预措施
Cohort 1
Participants that have initiated deucravacitinib
干预措施: Deucravacitinib (Drug)
Cohort 2
Participants that have initiated apremilast
干预措施: Apremilast (Drug)
结局指标
主要结局
Change in body surface area (BSA)
时间窗: At baseline and every 6 months up to 60 months or treatment discontinuation
Time from date of treatment initiation to date of discontinuation
时间窗: Up to 60 months
Dermatology life quality index (DLQI) response 0/1
时间窗: Up to 60 months
Investigator global assessment (IGA) response 0/1
时间窗: Up to 60 months
次要结局
- Change in dermatology life quality index (DLQI) response(At baseline to follow-up, up to 60 months)
- National psoriasis foundation (NPF) acceptable body surface area (BSA) response(At baseline to follow-up, up to 60 months)
- NPF target BSA response(At baseline to follow-up, up to 60 months)
- 75 percent improvement in Psoriasis area and severity index (PASI) score(At baseline and every 6 months up to 60 months or treatment discontinuation)
- PASI score response ≤ 3(At baseline to follow-up, up to 60 months)
- PASI score response ≤ 5(At baseline to follow-up, up to 60 months)
- PASI score change from baseline(At baseline to follow-up, up to 60 months)
- Change in investigator global assessment (IGA) score(Up to 60 months)
- Change in VAS: Fatigue Response(At baseline to follow-up, up to 60 months)
- Merit-based Incentive Payment System (MIPS) Clinical Response to Oral Systemic or Biologic Medications(At baseline to follow-up, up to 60 months)
- BSA ≤3%(At baseline to follow-up, up to 60 months)
- Change in VAS: Skin Pain response(At baseline to follow-up, up to 60 months)
- Change in DLQI response ≤5(At baseline to follow-up, up to 60 months)
- Change in visual analog scale (VAS): Itch response(At baseline to follow-up, up to 60 months)
研究者
研究点 (1)
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