A Prospective, Multi-center, Post-marketing, Observational Study to Evaluate the Safety and Effectiveness of Upadacitinib in Chinese Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 21
- 主要终点
- Percentage of Participants With Incidence of Serious Infections
研究概览
简要总结
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. This study will assess how safe and effective upadacitinib is in treating AD in adolescent and adult Chinese participants.
Upadacitinib is an approved drug for treating AD. Approximately 200 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in China.
Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of moderate to severe atopic dermatitis (AD) at the time of enrollment.
- •Chinese adolescents (≥12 to <18 years of age with body weight of ≥40 kg) or adults (≥18 years of age) at the time of enrollment.
- •Participants eligible for initiation of Upadacitinib treatment for AD, including any required screening tests indicated per China Label.
- •The decision to prescribe Upadacitinib is made prior to and independently of study participation.
排除标准
- •Participants who cannot be treated with Upadacitinib as per China label or by judgement of treating physician.
- •Currently participating in any interventional research studies.
结局指标
主要结局
Percentage of Participants With Incidence of Serious Infections
时间窗: Up to approximately 25 months
Incidence rate of serious infections in AD participants treated with Upadacitinib will be assessed.
次要结局
未报告次要终点