French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 600
- 试验地点
- 93
- 主要终点
- Compliance for AD Treatments
研究概览
简要总结
The objective of the study is to describe the therapeutic management of patients more than or equal to 18 years old eligible for systemic therapy or treated by systemic therapy for atopic dermatitis (AD). This study will be proposed to a sample of French dermatologists experienced in the management of AD, practicing in hospital centers and/or office-based dermatologists. The study will be conducted in real conditions of practice, systemic treatment decisions will be taken at the sole initiative of the participating physician irrespective of the patient enrollment decision. Each patient will be followed-up in routine care setting for 1 year.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form.
- •Patient with moderate to severe AD according to the Investigator's judgment and
- •Patient eligible to systemic treatment as Atopic Dermatitis Control Tool (ADCT) more than or equal to (≥) 7 and/or use topical corticosteroids (TCS) more than (>) 90 gram (g)/month and/or TCS are not advisable.
- •Patient currently under systemic treatment.
- •Able to understand and complete study-related questionnaires.
排除标准
- •Any condition that, in the opinion of the Investigator, may interfere with patient'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 patient from adequately completing, as per routine care, the schedule of visits and assessments
- •Patient receiving systemic therapy only for a disease other than AD.
- •Patient participating in any interventional clinical trial at the time of enrolment.
- •Patient is under tutorship or curatorship; patient under safeguard of justice or deprived of his/her liberty by an administrative or court decision
- •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
The study plans to collect information on patients during visits according to clinical practice. Enrolled patients will receive AD treatment of marketed drugs prescribed by the specialty physician. No investigational drug will be given for the purpose of this study.
结局指标
主要结局
Compliance for AD Treatments
时间窗: Baseline, month 6 and month 12
Compliance for AD treatments will be assessed by the physician.
Previous and Current Treatments for Atopic Dermatitis (AD)
时间窗: Baseline, month 6 and month 12
List of previous and current treatments for AD based on physician-reported data will be assessed.
Atopic Comorbidities: Previous and Current Therapeutic Management
时间窗: Baseline, month 6 and month 12
Description of previous and current therapeutic management of atopic comorbidities over time based on physician-reported data will be assessed.
Change from Baseline in Drug Survival for Systemic Treatments for AD by Name and Dose
时间窗: Baseline, month 6 and month 12
Drug survival is defined as the time from the start of treatment to the end or discontinuation of treatment with no changes. If a patient has multiple drug survival events for the same treatment, the longest drug survival will be used in the data summarization. The drug survival will be illustrated using a Kaplan-Meier plot.
次要结局
- Demographic Characteristics of Participants(Baseline)
- Medical History and AD history(Baseline)
- Change from Baseline in AD Severity(Baseline, month 6 and month 12)
- Atopic Comorbidities(Baseline, month 6 and month 12)
- Non-atopic Comorbidities(Baseline, month 6 and month 12)
- Use of Psychoactive Substances(Baseline, month 6 and month 12)
- Change from Baseline in Itch Assessment(Baseline, month 6 and month 12)
- Change from Baseline in Sleep Disturbance NRS(Baseline, month 6 and month 12)
- Change from Baseline in Skin Pain NRS(Baseline, month 6 and month 12)
- Change from Baseline in AD Disease Control Using the Atopic Dermatitis Control Tool (ADCT)(Baseline, month 6 and month 12)
- Change from Baseline in Dermatology Life Quality Index (DLQI)(Baseline, month 6 and month 12)
- Change from Baseline in Psychological Comorbidities Assessed using Hospital Anxiety and Depression Scale (HADS)(Baseline, month 6 and month 12)
- Cumulative Life Course Impairment (CLCI) - for Physicians in Hospital Centers(Baseline, month 6 and month 12)
- Change from Baseline in Patient's Treatment Satisfaction Score Using the Patient Global Assessment of Treatment Effect (PGATE)(Baseline, month 6 and month 12)
- Evolution of Atopic Comorbidities(Baseline, month 6 and month 12)
- Management of AD from First Diagnosis(Baseline, month 6 and month 12)
- Therapeutic Education(Baseline, month 6 and month 12)
- Cost of Emollients and Hygiene Products(At month 12)
- Sick Leaves Related to AD(Baseline, month 6 and month 12)
- Hospitalization with Overnight Stay Related to AD(Baseline, month 6 and month 12)