Atopic Dermatitis Disease Registry of Adult and Adolescent Patients Initiating or Switching Systemic Treatments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 1,000
- 试验地点
- 79
- 主要终点
- Number of Participants Augmenting AD treatment
研究概览
简要总结
The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.
The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.
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
- •Patients aged more than or equal to (≥) 12 years at the time of consent.
- •Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L
- •Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)
- •Signed informed consent for registry participation by the patient or parent/legal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.
排除标准
- •Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.
- •Insufficient understanding of the study by the patient and/or parent/guardian.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Atopic Dermatitis
This study plans to collect information on adolescent and adult patients with atopic dermatitis who initiate or switch any systemic treatment (eg, biologics, oral Janus kinase [JAK] inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil) for AD according to the country-specific prescribing information. During the study, investigators will prescribe medical products for treatment of AD per standard of care (SoC) and per medical judgment.
结局指标
主要结局
Number of Participants Augmenting AD treatment
时间窗: Baseline to up to 60 months
The number (and percentage) of patients augmenting AD treatment will be summarized descriptively.
Number of Participants Utilizing Atopic Dermatitis (AD) Treatment
时间窗: Baseline to up to 60 months
The number (and percentage) of participants taking AD treatments and treatments per patient will be described.
Duration of Treatment
时间窗: Baseline to up to 60 months
The duration of AD treatments will be summarized descriptively.
AD Treatment Sequences
时间窗: Baseline to up to 60 months
The ordering of AD treatments will be summarized descriptively.
Number of Participants Initiating AD Treatments with Reasons
时间窗: Baseline to up to 60 months
The number (and percentage) of patients initiating AD treatment and reasons for initiation will be summarized descriptively.
Number of Participants Interrupting AD Treatment
时间窗: Baseline to up to 60 months
The number (and percentage) of patients interrupting AD treatment and reasons for treatment interruption will be summarized descriptively.
Number of Participants Discontinuing AD Treatment
时间窗: Baseline to up to 60 months
The number (and percentage) of patients discontinuing AD treatment and reasons for treatment discontinuation will be summarized descriptively.
Number of Participants Switching AD Treatments
时间窗: Baseline to up to 60 months
The number (and percentage) of patients switching AD treatment and reasons for treatment switch will be summarized descriptively.
Number of Participants Modifying AD Treatment Dose
时间窗: Baseline to up to 60 months
The number (and percentage) of patients modifying AD treatment dose, reasons for dose modification, and dosing will be summarized descriptively.
Change from Baseline in Extent and Severity of AD Measured with Eczema Area and Severity Index (EASI)
时间窗: Baseline to up to 60 months
Clinical outcomes measured using EASI will be summarized at the start of a treatment episode and each follow-up time point.
Change from Baseline in Extent and Severity of AD Measured with Body Surface Area (BSA)
时间窗: Baseline to up to 60 months
Clinical outcomes measured using BSA will be summarized at the start of a treatment episode and each follow-up time point.
Change from Baseline in Extent and Severity of AD Measured with Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)
时间窗: Baseline to up to 60 months
Clinical outcomes measured using vIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.
Change from Baseline in Extent and Severity of AD Measured with Revised Investigator's Global Assessment for Atopic Dermatitis (rIGA-AD)
时间窗: Baseline to up to 60 months
Clinical outcomes measured using rIGA-AD will be summarized at the start of a treatment episode and each follow-up time point.
Change in Atopic Dermatitis Control Test (ADCT) from Baseline
时间窗: Baseline to up to 60 months
The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.
Change in Patient Global Impression of Severity (PGIS) from Baseline
时间窗: Baseline to up to 60 months
The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.
Change in Itch severity as Measured with the Peak Pruritus Numeric Rating Scale (PP-NRS) from Baseline
时间窗: Baseline to up to 60 months
The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
Change in Skin Pain as Measured with Skin Pain Numeric Rating Scale (SP-NRS) from Baseline
时间窗: Baseline to up to 60 months
The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.
Change in Sleep Disturbance as Measured with Sleep Disturbance Numeric Rating Scale (SD-NRS) from Baseline
时间窗: Baseline to up to 60 months
The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis.
Remission of AD
时间窗: Baseline to up to 60 months
Total remission of all signs and symptoms of AD will be assessed.
次要结局
- Sociodemographic characteristics of Participants(Baseline)
- Ethnic Origin in Combination with Fitzpatrick Scale(Baseline)
- Disease characteristics of Participants(Baseline)
- Change from Baseline in Dermatology-specific Quality of Life Measure with Dermatology Life Quality Index (DLQI)(Baseline to up to 60 months)
- Change from Baseline in Dermatology-specific Quality of Life Measure with Children's Dermatology Life Quality Index (CDLQI)(Baseline to up to 60 months)
- Change from Baseline in Burden of Assessment Using Patient Health Questionnaire-9 (PHQ-9)(Baseline to up to 60 months)
- Change from Baseline in AD Specific Work and Classroom Productivity and Impairment Assessed Using WPAI+CIQ(Baseline to up to 60 months)
- Change from Baseline in Treatment Satisfaction Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-9)(Baseline to up to 60 months)
- Visits with Specialty of Attending Healthcare Provider and Reason for Visit(Baseline to up to 60 months)
- Hospitalizations for AD(Baseline to up to 60 months)
- Prevalence of Comorbid Atopic Conditions(Baseline to up to 60 months)
- Incidence of Comorbid Atopic Conditions(Baseline to up to 60 months)
- Change from Baseline in Asthma Control Assessed with Asthma Control Questionnaire-5 (ACQ-5)(Baseline to up to 60 months)
- Occurrence of Concomitant Medication use for AD and Selected Comorbidities(Baseline to up to 60 months)
- Number of Adverse Events (SAEs)(Baseline to up to 60 months)
- Number of Serious Adverse Events (SAEs)(Baseline to up to 60 months)