Real World Utilization of Upadacitinib in Adult and Adolescent Patients Living With Moderate to Severe Atopic Dermatitis (AD-VISE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 873
- 试验地点
- 140
- 主要终点
- Upadacitinib (UPA) Utilization Patterns
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, important information is missing on the use patterns and outcomes with upadacitinib in a real-world setting. Therefore, the purpose of this observational study is to help inform real-world usage patterns regarding the safety and effectiveness and duration of response of upadacitinib in adolescent and adult AD participants >=12 years old in the real-world setting.
Upadacitinib is an approved drug being developed for the treatment of AD. Around 975 adolescent and adult participants who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled worldwide.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician confirmed diagnosis of atopic dermatitis (AD) or atopic eczema at baseline.
- •Symptom onset >=1-year prior to baseline.
- •Initiation of upadacitinib treatment for AD is indicated and prescribed per local label.
- •The decision to prescribe UPA is made prior to and independently of study participation.
- •Medical and medication history available for previous 6 months.
- •Participants who can understand the questionnaires, with parental support as required for adolescents.
- •Participants who are able to understand and communicate with the investigator and comply with the requirements of the study.
- •Participants who are willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., tablet).
- •Participants who are willing and able to complete the patient-reported questionnaires.
排除标准
- •Participants who are currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).
结局指标
主要结局
Upadacitinib (UPA) Utilization Patterns
时间窗: Up to Approximately 24 Months
UPA utilization patterns will be achieved by (i) providing descriptive statistics of patient demographics and disease characteristics for patients who starting UPA 15 mg at baseline and patients who starting UPA 30 mg at baseline, respectively; (ii) calculating number and proportion of patients with different UPA and concomitant therapy changes throughout the observation period, and the rationale for any changes.
Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) 0/1
时间窗: Month 4
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD 0/1 at Month 4
时间窗: Month 24
vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of AD globally. A 5-point scale is used to measure the severity of disease at the time of the investigator's evaluation of the participant ranging from 0 - Clear (no inflammatory signs of atopic dermatitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory hyperpigmentation and/or hypopigmentation may be present.) to 4 - Severe (marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification.
次要结局
- Modification of UPA or Concomitant AD Therapy and Associated Timing, Reasons(Month 24)
- Percentage of Participants Achieving EASI <=1(Up to Approximately 24 Months)
- Percentage of Participants Achieving WP-NRS <=3(Up to Approximately 24 Months)
- Percentage of Participants Achieving Patient Oriented Eczema Measurement (POEM) Score <=2(Up to Approximately 24 Months)
- Percentage of Participants Remaining on Upadacitinib Once Daily(Up to Approximately 24 Months)
- Percentage of Participants who are "Extremely Satisfied" or "Very Satisfied" with their AD Treatment using the Patient Global Impression of Treatment for Atopic Dermatitis (PGIT-AD)(Up to Approximately 24 Months)
- Percentage of Participants Achieving vIGA-AD 0/1 Among Participants Who Achieved vIGA-AD at Month 4(Up to Approximately 24 Months (Excluding Month 24 - Primary Outcome))
- Percentage of Participants Achieving EASI <=5.9(Up to Approximately 24 Months)
- Percentage of Participants Achieving EASI <=7(Up to Approximately 24 Months)
- Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0/1(Up to Approximately 24 Months)
- Percentage of Participants Achieving EASI 100 Among Participants Who Achieved EASI 100 at Month 4(Up to Approximately 24 months)
- Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75(Up to Approximately 24 months)
- Percentage of Participants Achieving Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1(Up to Approximately 24 Months)
- Percentage of Participants Achieving WP-NRS reduction >=4(Up to Approximately 24 Months)
- Percentage of Participants Achieving POEM <=7(Up to Approximately 24 Months)
- Percentage of Participants Achieving EASI 90(Up to Approximately 24 Months)
- Percentage of Participants Achieving EASI 100(Up to Approximately 24 Months)
- Percentage of Participants Achieving vIGA-AD 0/1(Up to Approximately 24 Months (Excluding Month 4 - Primary Outcome))
- Percentage of Participants Achieving DLQI Score <=5(Up to Approximately 24 Months)
- Percentage of Participants Achieving Atopic Dermatitis Control Tool (ADCT) <7 (control)(Up to Approximately 24 Months)
- Percentage of Participants Achieving POEM Reduction >=4(Up to Approximately 24 Months)
- Percentage of Participants Achieving DLQI Score of 0/1 Among Participants Achieving DLQI Score of 0/1 at Month 4(Up to Approximately 24 Months)
- Absolute Score and Change from Baseline in POEM(Up to Approximately 24 Months)
- Absolute Score and Change from Baseline in Work Productivity and Activity Impairment Index for Atopic Dermatitis (WPAI-AD)(Up to Approximately 24 Months)
- Time to Achieve EASI 75(Up to Approximately 24 months)
- Time-Weighted EASI Score(Up to Approximately 24 Months)
- Time-Weighted WP-NRS Score(Up to Approximately 24 Months)
- Percentage of Participants Achieving DLQI reduction >=4(Up to Approximately 24 Months)
- Percentage of Participants Achieving ADCT reduction >=5(Up to approximately 24 Months)
- Percentage of Participants Achieving WP-NRS 0/1 Among Participants Who Achieved WP-NRS 0/1 at Month 4(Up to Approximately 24 Months)
- Percentage of Participants Achieving EASI 75 Among Participants Who Achieved EASI 75 at Month 4(Up to Approximately 24 months)
- Absolute Score and Change from Baseline in DLQI(Up to Approximately 24 Months)
- Change from Baseline in the Number of AD-Related Physician Office or Hospital Visits(Up to Approximately 24 Months)
- Time to Achieve EASI 100(Up to Approximately 24 months)
- Time to Achieve POEM <=2(Up to Approximately 24 Months)
- Time to Achieve ADCT <7(Up to Approximately 24 Months)
- Percentage of Participants Achieving EASI 90 Among Participants Who Achieved EASI 90 at Month 4(Up to Approximately 24 months)
- Absolute Score and Change from Baseline in ADCT(Up to Approximately 24 months)
- Time to Achieve EASI 90(Up to Approximately 24 months)
- Time to Achieve vIGA-AD 0/1(Up to Approximately 24 Months)
- Time-Weighted vIGA-AD Score(Up to Approximately 24 Months)
- Percentage of Participants Achieving Combined Treatment Targets of EASI <8, DLQI <=5, and WP-NRS <=4(Up to Approximately 24 Months)
- Percentage of Participants Achieving ADCT Reduction <7 Among Participants Who Achieved ADCT Reduction <7 at Month 4(Up to approximately 24 Months)
- Absolute Score and Change from Baseline in Body Surface Area (BSA)(Up to Approximately 24 Months)
- Absolute Score and Change from Baseline in WP-NRS(Up to Approximately 24 Months)
- Absolute Score and Change from Baseline in PGIT-AD(Up to Approximately 24 Months)
- Time to Achieve WP-NRS 0/1(Up to Approximately 24 Months)
- Percentage of Participants Achieving Treatment Target WP-NRS <=4(Up to Approximately 24 Months)
- Absolute Score and Change from Baseline in EASI(Up to Approximately 24 months)
- Absolute Score and Change from Baseline in vIGA-AD(Up to Approximately 24 months)
- Change from Baseline in Flare Frequency and Duration(Up to Approximately 24 Months)
- Time to Achieve DLQI Score of 0/1(Up to Approximately 24 Months)
- Time-Weighted DLQI Score(Up to Approximately 24 Months)
- Percentage of Participants Achieving Treatment Target EASI <8(Up to Approximately 24 Months)
- Percentage of Participants Achieving Treatment Target DLQI <=5(Up to Approximately 24 Months)