REal-world Utilization and Treatment Target ACHievement With Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 38
- 主要终点
- Number of participants with a dose change
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.
Upadacitinib is an approved drug for treating AD. Approximately 1000 adolescents and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in up to 40 sites in China.
Participants will receive oral upadacitinib tablets as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 12 months.
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
- •Adolescents (body weight >= 40 kg at the Baseline Visit for patients between >= 12 and < 18 years of age) and adults at the time of enrollment.
- •Clinical diagnosis of moderate to severe atopic dermatitis at the time of enrollment.
- •UPA treatment is indicated for AD and prescribed as per Chinese label / SmPC.
- •The decision to prescribe UPA is made prior to and independent of study participation.
- •The participant should not be treated with UPA prior to this study.
- •Participants who are willing and able to participate in the collection of patient-reported data, including ePROs and eDiary via apps.
- •The participant (legal representative for adolescents) voluntarily signed an informed consent before any study-related activities are conducted.
排除标准
- •The participant is currently participating in interventional research (not including noninterventional study, observational study, or registry participation).
- •Any circumstances that the investigator believes may limit the patient's participation and compliance with study procedures.
研究组 & 干预措施
Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label.
结局指标
主要结局
Number of participants with a dose change
时间窗: 12 Months
Dose change includes: Changed dose, dose escalation or dose tapering.
Number of participants with interruption or permanent discontinuation
时间窗: 12 Months
Interruption: Upadacitinib is temporarily interrupted due to atopic dermatitis disease condition, economic, tolerance, AE, or personal reasons, and the investigator considers there is still possibility of Upadacitinib re-initiating within the patient's study follow-up period. Discontinuation: Upadacitinib is permanently discontinued for safety or any other reasons, and the investigator considers Upadacitinib will not be used again, at least within the participant's study follow-up period.
Number of participants with Upadacitinib drug compliance
时间窗: 12 Months
The participants missed medication, regardless of reason, or incompliance with the prescription as per medical advice are to be recorded in the eDiary, choosing the reason: "Forgot, Self-reduction of medication, interruption because of AE, interruption not due to safety/tolerability, for other reasons". If no eDiary entries are found within 30 days before the visit, the participant will need to complete the following question in ePRO: timely Upadacitinib intake per medical advice in past 30 days (yes/no); if "no", days-off-drug, intentionally or accidentally, and if "intentionally", reason for incompliance with medical prescription.
次要结局
未报告次要终点