Sotyktu (Deucravacitinib) Post-Marketing Surveillance in Korean Patients With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 505
- 试验地点
- 2
- 主要终点
- Number of participants with adverse drug reactions (ADRs)
研究概览
简要总结
The purpose of this observational study is to describe the safety and effectiveness of deucravacitinib in participants in Korea that have been 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants ≥19 years of age
- •Diagnosis of moderate-to-severe plaque psoriasis
- •Candidate for phototherapy or systemic therapy
- •Will begin deucravacitinib according to approved product label
排除标准
- •Participants prescribed deucravacitinib for therapeutic indications not approved in Korea
- •Participants for whom deucravacitinib is contraindicated as clarified in Korean prescribing information by ministry of food and drug safety (MFDS)
研究组 & 干预措施
Participants diagnosed with moderate-to-severe plaque psoriasis
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Number of participants with adverse drug reactions (ADRs)
时间窗: Up to 24 weeks from treatment initiation
Number of participants with serious adverse events (SAEs)
时间窗: Up to 24 weeks from treatment initiation
Number of participants with unexpected adverse events (AEs)
时间窗: Up to 24 weeks from treatment initiation
Number of participants with unexpected serious adverse events (SAEs)
时间窗: Up to 24 weeks from treatment initiation
Number of participants with adverse events (AEs)
时间窗: Up to 24 weeks from treatment initiation
Number of participants with serious adverse drug reactions (SADRs)
时间窗: Up to 24 weeks from treatment initiation
Number of participants with unexpected adverse drug reactions (ADRs)
时间窗: Up to 24 weeks from treatment initiation
Number of participants with unexpected serious adverse drug reactions (SADRs)
时间窗: Up to 24 weeks from treatment initiation
次要结局
- Proportion of participants with static Physician Global Assessment (sPGA) of 0 or 1(At Week 16 and/or Week 24 post treatment initiation)
- Number of participants achieving Psoriasis Area and Severity Index (PASI) 75 (at least a 75% improvement in PASI score from baseline)(At Week 16 and/or Week 24 post treatment initiation)