Prospective, Non-interventional, Observational Study for Multi-dimensional Assessment of Signs, Symptoms, Quality of Life and Disease Control of Long-term Treatment With Dupilumab in Patients With Atopic Dermatitis (≥6 Years)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 900
- 试验地点
- 55
- 主要终点
- Number of patients who maintain Eczema Area and Severity Index (EASI) ≤ 7 OR peak pruritus Numerical Rating Scale (NRS) ≤ 4 OR Dermatology Life Quality Index (DLQI) ≤ 5
研究概览
简要总结
This is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control. The aim of this NIS is the characterization of the AD patient population in Germany, receiving dupilumab under everyday conditions in terms of their medical history, socio-demographic and disease-related characteristics, associated atopic comorbidities and type 2 inflammation diseases, concomitant therapy as well as previous systemic and ongoing AD treatments. In addition to the therapeutic response rate at Month 6, the long-term efficacy of dupilumab at Month 12 and Month 24 will be assessed by additional outcomes by measuring disease control in AD patients using questionnaires such as Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). In addition, this NIS aims to assess the dosing pattern of dupilumab for AD, including variations in dosing regimen, reason for dupilumab treatment initiation or discontinuation, or change in therapy and concomitant therapies and duration of treatment. In addition, the effect of dupilumab in adult and pediatric AD patients with associated atopic comorbidities or type-2 inflammation diseases are observed, which corresponds to the clinical care situation. Finally, this NIS aims to collect long-term safety data in adult, adolescent and pediatric AD patients treated with dupilumab. Individual observation period is 2 years or until dupilumab is discontinued. Visits will be scheduled according to standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients are at least 6 years of age at the baseline visit.
- •Initial treatment with dupilumab was initiated in adults and adolescents 12 years of age and older with moderate to severe AD, or in children 6 to 11 years of age with severe AD according to the Summary of Product Characteristics.
- •Patients or their guardians are able to understand and complete the study-related questionnaires.
- •Signing a written informed consent form by the patients before the initiation of documentation within the framework of this NIS or informed consent of parents/guardian, if applicable.
排除标准
- •Patients who have a contraindication for dupilumab based on the current Summary of Product Characteristics.
- •Patients who have already been treated with dupilumab for more than 7 days.
- •Any acute or chronic diseases, which, in the opinion of the attending physician, would impair the patient's ability to complete questionnaires or participate in this study or could affect the interpretation of the results.
- •Participation in an ongoing interventional or observational study, which, in the opinion of the attending physician, could affect the assessment of the current study.
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
AD patients treated with dupilumab
Patients ≥6 years of age in whom dupilumab therapy was initiated to treat their severe AD (6-11 years) or moderate to severe AD (adult and adolescent patients ≥12 years of age) based on the patient's medical requirements and standards of best medical practice.
结局指标
主要结局
Number of patients who maintain Eczema Area and Severity Index (EASI) ≤ 7 OR peak pruritus Numerical Rating Scale (NRS) ≤ 4 OR Dermatology Life Quality Index (DLQI) ≤ 5
时间窗: From Month 6 to Month 12
EASI is a Measure used in clinical practice and clinical trials to assess the severity and extent of Atopic Dermatitis (AD). Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\]), higher scores indicated greater severity. DLQI is a questionaire with a score system of 0 to 30 the high score is indicative of poor QoL
Mean percent change from baseline in Atopic Dermatitis Control Tools (ADCT) score (≥12 years)
时间窗: From baseline to Week 52
Atopic dermatitis control tool (ADCT) is a validated, brief and easy scored tool designed to evaluate patient-perceived control of atopic dermatitis, to foster communication between patients and their physicians and help appropriate decision- making. ADCT questionnaire assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control. ADCT is a questionnaire to assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control.
Mean percent change from baseline in Recap of atopic eczema (RECAP) score (6-11 years)
时间窗: From baseline to Week 52
Recap of atopic eczema (RECAP) is a seven-item questionnaire designed to capture the experience of eczema control in all ages and eczema severities. Patient's who turn 12 years during the course of study will continue to complete RECAP.
次要结局
- Treating physician reported effectiveness data: Change from baseline in IGA score after 6, 12, and 24 months dupilumab therapy(From baseline up to 24 months)
- Treating physician reported effectiveness data: Absolute change from baseline in EASI score after 6, 12 and 24 months of dupilumab therapy(From baseline up to 24 months)
- Event rate (per patient year) by type of dupilumab related TEAEs during the observational period(From Baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Recap of atopic eczema (RECAP) score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean Absolute Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance score after 6, 12, and 24 months of dupilumab therapy.(From baseline up to 24 months)
- Incidence of dupilumab-related TEAEs during the observation period.(From baseline up to 24 months)
- Treating physician reported effectiveness data: Absolute change from baseline in IGA score after 6, 12, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Treating physician reported effectiveness data: Change from baseline in body surface area (BSA) after 6, 12, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in RECAP score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in At baseline Questionnaire on Experience with Skin complaints (QES) score after 6, 12, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in Patient Global Assessment (PtGA) score after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Treating physician reported effectiveness data.: Number of patients achieving EASI-75 (improvement in EASI score from baseline of ≥ 75%) after 6, 12 and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: : Mean percent change from baseline in Asthma control questionnaire-5 (ACQ-5)-Scores, assessed only in patients with co-existing Asthma after 3, 6, 9,12, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient and treatment characteristics reported by the physician or patient: Cost of non-reimbursable supplementary therapy [€/month](From baseline up to 24 months)
- Incidence of treatment emergent adverse events (TEAEs) during the observation period(From baseline up to 24 months)
- Event rate (per patient year) by type of TEAEs during the observation period.(From baseline up to 24 months)
- Treating physician reported effectiveness data: Percentage change from baseline in EASI score after 6, 12, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in ADCT score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Dermatology Life Quality Index/Children's Dermatology Life Quality Index (DLQI/CDLQI) score after 6, 12, and 24 months of dupilumab therapy.(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in Dermatology Life Quality Index (DLQI)/Children's Dermatology Life Quality Index (CDLQI) score after 6, 12, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on quality of life (QoL) data: Mean absolute change from baseline in Atopic Dermatitis Control Test (ADCT) score after 3, 6, 9, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Patient Oriented Eczema Measure (POEM) score after 6, 12, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in POEM score after 6, 12, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean Percent Change from baseline in PROMIS sleep disturbance score after 6, 12, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Mean absolute change from baseline in Allergic Visual analogue Scales ([Allergic-VAS] only patients with co-existing overall allergic symptoms) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Sinus Control Test (SCT) score, only assessed in patients with co-existing chronic rhinosinusitis after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient and treatment characteristics reported by the physician or patient: Reasons for initiating dupilumab treatment(At baseline)
- Patient and treatment characteristics reported by the physician or patient: Number of medical appointments due to AD(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in At baseline Questionnaire on Experience with Skin complaints (QES) score after 6, 12, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Patient Global Assessment (PtGA) score after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Mean percent change from baseline in MACVIA-ARIA Sentinel Network conjunctivitis Visual Analog Score (MASK-conjunctivitis VAS score) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in SCT score, only assessed in patients with co-existing chronic rhinosinusitis after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Patient and treatment characteristics reported by the physician or patient: Reasons for discontinuation of dupilumab treatment (if the discontinuation was before end of study)(Up to 24 months)
- Patient and treatment characteristics reported by the physician or patient: Number of sick-leave days away from work/school due to AD(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in MACVIA-ARIA Sentinel Network conjunctivitis Visual Analog Score (MASK-conjunctivitis VAS score), after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy.(From baseline up to 24 months)
- Patient and treatment characteristics reported by the physician or patient: Medical history of disease(At baseline)
- Patient and treatment characteristics reported by the physician or patient: Current topical and/or systemic AD treatment of the last 4 weeks before baseline visit (dosage, type)(At baseline)
- Patient and treatment characteristics reported by the physician or patient: Number of visits to alternative practitioners and complementary care physicians(From baseline upto 24 months)
- Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in Asthma control questionnaire-5 (ACQ-5)-Scores, assessed only in patients with co-existing Asthma) after 3, 6, 9,12, 15, 18, and 24 months of dupilumab therapy(From baseline up to 24 months)
- Mean percent change from baseline in Allergic Visual Analogue Scales ([Allergic-VAS] only patients with co-existing overall allergic symptoms) after 3, 6, 9, 12, 15, 18, and 24 months of dupilumab therapy(From Baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean absolute change from baseline in MACVIA-ARIA Sentinel Network Rhinitis Visual Analog Score (MASK-Rhinitis VAS score).(From baseline up to 24 months)
- Patient reported effectiveness and impact on QoL data: Mean percent change from baseline in MACVIA-ARIA Sentinel Network Rhinitis Visual Analog Score (MASK-Rhinitis VAS score)(From baseline up to 24 months)
- Patient and treatment characteristics reported by the physician or patient: Socio -demographic data(At baseline)
- Patient and treatment characteristics reported by the physician or patient: Comorbidities/smoker status/alcohol usage(At baseline)
- Patient and treatment characteristics reported by the physician or patient: Prior systemic AD treatment (including balneophototherapy and/or UV therapy)(At baseline)
- Patient and treatment characteristics reported by the physician or patient: Current treatment for co-existing type 2 inflammatory and atopic diseases(At baseline)