A Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD With Prurigo Nodularis in the Real World in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Percentage of participants achieving Worst Pruritus Numerical Rating Scale (WP-NRS) reduction ≥ 4.
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. Around one-third of patients with AD have had at least 1 incidence of prurigo nodularis (PN), which is characterized by intense, persistent itchy skin and sometimes pain with burning. In this study, the effectiveness of upadacitinib (UPA) will be assessed in participants with prurigo-type AD in a real world (RW) setting in Japan.
UPA is an approved drug for the treatment of AD. Adults and adolescents who have been diagnosed with prurigo-type AD and prescribed UPA according to the label and practice in Japan will be enrolled in this observational study. The doctor's decision to prescribe UPA will be made prior to and independently of study participation. Approximately 200 participants will be enrolled in the study at 10 sites in Japan.
Participants will receive extended-release oral tablets of UPA once-daily for 48 weeks.
There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic.
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
- •Physician confirmed diagnosis of moderate to severe atopic dermatitis (AD) at baseline
- •AD symptom onset > 1 year prior to baseline
- •Initiation of UPA treatment for AD is indicated and prescribed per the label in Japan
- •Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at baseline
- •Presence of palpable prurigo nodules at baseline
排除标准
- •Prior treatment with UPA
- •Contraindications to UPA
- •Chronic pruritus resulting from another condition (e.g., neuropathic disorders) than AD, prurigo nodularis (PN)
- •PN caused by medication, metal allergy, infection, insect bite
- •Current participation in interventional research
研究组 & 干预措施
Upadacitinib
Adolescents and adults with moderate to severe prurigo-type AD, who are prescribed UPA according to the label and practice in Japan.
结局指标
主要结局
Percentage of participants achieving Worst Pruritus Numerical Rating Scale (WP-NRS) reduction ≥ 4.
时间窗: Up to Week 12
WP-NRS is a validated single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours in patients with moderate to severe AD, based on the following question: "On a scale 0 to 10, with 0 being 'no itch' and 10 being 'worst imaginable itch', how would you rate your itch at its worst during the past 24 hours?"
次要结局
未报告次要终点