A Post-Marketing Observational Study to Evaluate Safety and Effectiveness of Upadacitinib in Adolescent Patients Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 61
- 主要终点
- Percentage of Participants with Serious Infection
研究概览
简要总结
Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, these studies included a limited number of adolescent patients in Japan. Therefore, the purpose of this observational study is to evaluate safety and effectiveness of upadacitinib in adolescent AD participants age 12 to <18 years old in Japan in the real-world setting.
Upadacitinib is an approved drug being developed for the treatment of AD in adolescents in Japan. Around 170 participants age 12 to <18 who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled at multiple sites in Japan.
Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years.
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 and will be asked to provide additional information by questionnaire at each visit.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are diagnosed with atopic dermatitis (AD).
- •History of topical anti-inflammatory agents such as topical steroids and topical tacrolimus for AD.
- •Participants initiating upadacitinib for the treatment of AD in routine clinical practice.
- •Body weight >=30 kg at the start of dosing.
排除标准
- •Prior treatment with upadacitinib
- •Currently participating in another registrational clinical research study
- •Participants for whom upadacitinib is contraindicated
结局指标
主要结局
Percentage of Participants with Serious Infection
时间窗: 2 Years
Serious infection is defined as any infection identified as an Infection Company MedDRA Query that meets seriousness criteria
次要结局
- Percentage of Participants Achieving an Improvement in Worst Pruritus-NRS >=4(2 Years)
- Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) including Safety Specification(2 Years)
- Absolute Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)(Up to 2 Years)
- Percent Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)(Up to 2 Years)
- Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1(2 Years)
- Absolute Change from Baseline in Patient Oriented Eczema Measure (POEM) Score(2 Years)
- Percentage of Participants Achieving a Clinically Meaningful Improvement in POEM(2 Years)
- Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) Related to Impact on Bone Growth(2 Years)
- Percentage of Participants Achieving Worst Pruritus-NRS 0/1(2 Years)
- Percent Change from Baseline in POEM Score(2 Years)