NCT06382987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 Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年1月22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
- 600
- 试验地点
- 2
- 主要终点
- Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib.
研究概览
简要总结
This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast.
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
- •Japanese adult participants aged 18 years old or older
- •Physician-reported diagnosis of plaque psoriasis
- •Newly initiating deucravacitinib or apremilast according to the label
- •Participants who have signed informed consent
排除标准
- •Participants currently participating in or planning to participate in an interventional clinical trial
- •Patients enrolled in deucravacitinib post-marketing surveillance study (ClinicalTrial.gov ID: NCT05633264)
- •Previous treatment experience with the treatment of interest (e.g. patients who have history of apremilast will not be eligible to be enrolled in apremilast arm of the study and similar for deucravacitinib)
研究组 & 干预措施
Participants that have initiated deucravacitinib treatment
干预措施: Deucravacitinib (Drug)
Participants that have initiated apremilast treatment
干预措施: Apremilast (Drug)
结局指标
主要结局
Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib.
时间窗: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up
时间窗: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up
时间窗: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up
时间窗: 1 month, 3 months, 6 months and every 6 months up to 5 years
Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation)
时间窗: 1 month, 3 months, 6 months and every 6 months up to 5 years
次要结局
- Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
- Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up(1 month, 3 months, 6 months and every 6 months up to 5 years)
研究者
研究点 (2)
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