Post-marketing Surveillance of Spesolimab I.V. Infusion in Improvement of Generalized Pustular Psoriasis (GPP) With Acute Symptoms in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Incidence of adverse drug reactions (ADRs)
研究概览
简要总结
Non-interventional cohort study in patients with newly initiated Spesolimab to evaluate the incidence of adverse drug reactions and to understand generalized pustular psoriasis (GPP) disease activities in the real world setting.
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
- •GPP patients with acute symptoms who are administered Spesolimab Intravenous (I.V.) Infusion in Japan
- •Patients who have never been treated with Spesolimab I.V. Infusion before enrolment
排除标准
- 未提供
研究组 & 干预措施
Patients with generalized pustular psoriasis (GPP)
干预措施: Spesolimab (Drug)
结局指标
主要结局
Incidence of adverse drug reactions (ADRs)
时间窗: Up to 36 weeks
Incidence of adverse drug reactions (ADRs). An ADR is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorization or from occupational exposure. Conditions of use outside the marketing authorization include off-label use, overdose, misuse, abuse and medication errors.
次要结局
未报告次要终点