A Prospective, Observational Study of Canadian Patients Receiving Dupixent® for Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 305
- 试验地点
- 59
- 主要终点
- Percentage of participants achieving a reduction in EASI of at least 75% at 18 months
研究概览
简要总结
This is a prospective, 18-month observational study of adult, adolescent and pediatric Canadian participants with Atopic Dermatitis (AD) commonly known as Eczema, who receive treatment with Dupixent for moderate-to-severe AD (msAD) according to the Canadian-specific prescribing information (in accordance with the Canadian Dupixent Product Monograph). The study will be conducted in approximately 30 centers in Canada to assess participants of all ethnicities and races. At each participating site, all AD participants who receive an initial prescription for Dupixent will be invited to participate in this study, until the Canadian enrollment goal is achieved.
详细描述
The duration of the study for each participant will be of 18 months.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 6 years or older at baseline visit (Canada has received the country's regulatory approval for use of Dupixent treating msAD for these ages).
- •Participant is initiating dupilumab as part of routine clinical care through the Dupixent Patient Support Program (PSP) for the treatment of msAD, as per reimbursement criteria. Decision to treat with dupilumab must have been reached prior to and independently of recruitment in the study.
- •Have a physician's diagnosis of msAD.
- •Provided signed informed consent or parental/legally acceptable representative consent and/or participant assent. During the study, subjects will continue to receive maintenance therapies for their AD as clinically indicated and as per usual medical practice.
- •Participant or Parental representative able to understand English and/or Canadian French to complete study-related questionnaires.
排除标准
- •Participants who have a contraindication to the drug according to the Canadian-specific prescribing information label.
- •Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the participant from adequately completing the schedule of visits and assessments.
- •Participants currently participating in any interventional clinical trial which modifies participant care.
- •Prior use of Dupixent within 6 months of the baseline visit.
- •Participants not willing to sign the Informed Consent Form.
研究组 & 干预措施
Participants with msAD
Canadian msAD participants (ages 6+) who receive Dupixent for msAD according to the Canadian-country specific prescribing information (in accordance with the Canadian Dupixent Product Monograph)
结局指标
主要结局
Percentage of participants achieving a reduction in EASI of at least 75% at 18 months
时间窗: Month 18
EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics \[erythema, thickness (induration, papulation, and edema), scratching (excoriation), and lichenification\] will each be assessed for severity by the Investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage of each body area assessed: head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0 (0%), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Total score is the sum of all subscores. EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition. Data will be assessed to understand real-world effectiveness of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD using EASI score.
Percentage of participants achieving a reduction in Eczema Area and Severity Index (EASI) of at least 75% at 6 months
时间窗: Month 6
EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics \[erythema, thickness (induration, papulation, and edema), scratching (excoriation), and lichenification\] will each be assessed for severity by the Investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage of each body area assessed: head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0 (0%), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Total score is the sum of all subscores. EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition. Data will be assessed to understand real-world effectiveness of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD using EASI score.
Percentage of participants achieving a reduction in EASI of at least 75% at 12 months
时间窗: Month 12
EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics \[erythema, thickness (induration, papulation, and edema), scratching (excoriation), and lichenification\] will each be assessed for severity by the Investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage of each body area assessed: head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0 (0%), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Total score is the sum of all subscores. EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition. Data will be assessed to understand real-world effectiveness of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD using EASI score.
次要结局
- Change from baseline in Skin pain/soreness numerical rating scale (NRS)(From baseline to 6 months, 12 months, 18 months post-Dupixent initiation)
- Reasons for discontinuation of Dupixent therapy(From baseline up to 18 months post-Dupixent initiation)
- Change from baseline in sleep Disturbance NRS scores post-Dupixent initiation(From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation)
- Change from baseline in Peak Pruritus NRS (PP-NRS)(From baseline to 6 months, 12 months, 18 months post-Dupixent initiation)
- Change from baseline in the dermatology life quality index (DLQI)/the Children's Dermatology Life Quality Index (CDLQI) scores post-Dupixent initiation(From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation)
- Number of gaps in Dupixent treatment(From baseline up to 18 months)
- Change from baseline in height(From baseline to 6 months, 12 months and 18 months post- Dupixent initiation)
- Reasons for initiation of new AD treatments(From baseline up to 18 months)
- Disease characteristics at baseline: EASI score(At baseline)
- Dupixent dosing regimen(From baseline up to 18 months)
- Number of missed Dupixent doses over 18 months per participant(From baseline up to 18 months)
- Reasons for discontinuation and/or switching AD treatments(From baseline up to 18 months)
- Change from baseline in Body Surface Area of Atopic Dermatitis Involvement (BSA) score(From baseline to 6 months, 12 months, and 18 months post- Dupixent initiation)
- Change from baseline in Hospital Anxiety and Depression Scale (HADS) score(From baseline to 6 months, 12 months, 18 months post-Dupixent initiation)
- Change from baseline in skin feeling hot or burning NRS(From baseline to 6 months, 12 months, 18 months post-Dupixent initiation)
- Mean time to Dupixent discontinuation(From baseline up to 18 months post-Dupixent initiation)
- Percentage of participants who initiated Dupixent and remained on treatment(At 3 months, 6 months, 12 months and 18 months post- Dupixent initiation)
- Disease characteristics at baseline: BSA score(At baseline)
- Disease characteristics at baseline: Time between diagnosis and Dupixent prescription(At baseline)
- Change from baseline in EASI score(From baseline to 6 months, 12 months, and 18 months post- Dupixent initiation)
- Percentage of participants with Adverse Events (AEs) or Serious Adverse Events (SAEs)(From baseline up to 18 months post-Dupixent initiation)
- Median time to Dupixent discontinuation(From baseline up to 18 months post-Dupixent initiation)
- Most commonly used Dupixent dosing regimens(From baseline up to 18 months)
- Change from baseline in HADS(From baseline to 6 months, 12 months and 18 months post- Dupixent initiation)
- Change from baseline in sleep disturbance NRS scores post-Dupixent initiation(From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation)
- Change from baseline in BMI(From baseline to 6 months, 12 months and 18 months post- Dupixent initiation)
- Number of participants with demographic characteristics(From baseline up to 18 months)
- Change from baseline in Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) scores post-Dupixent initiation(From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation)
- Change from baseline in Work Productivity and Activity Impairment Questionnaire+Classroom Impairment Questions for AD (WPAI-CIQ-AD) scores post-Dupixent initiation(From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation)
- Change from baseline in Dermatitis Family Impact (DFI) score post-Dupixent initiation(From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation)
- Concomitant treatments received(From baseline up to 18 months)
- Dupixent treatment duration(From baseline up to 18 months)
- Change from baseline in weight(From baseline to 6 months, 12 months and 18 months post- Dupixent initiation)
- Longest gap in Dupixent treatment(From baseline up to 18 months)
- AD treatments to which participants switch when discontinuing dupixent(From baseline up to 18 months)