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临床试验/NCT06169527
NCT06169527进行中(未招募)不适用

French Prospective Observational Study of Patients Receiving Dupilumab for Atopic Dermatitis.

Sanofi42 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2023年11月28日最近更新:
适应症
干预措施
相关药物

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
303
试验地点
42
主要终点
Atopic comorbidities and treatments change from baseline

研究概览

简要总结

This is a long-term study to collect data over 3 years in order to find out what is likely to happen in the future regarding participants 6 years of age and older who receive dupilumab for Atopic Dermatitis (AD) commonly known as Eczema, and to characterize real-world effectiveness, safety and use patterns of dupilumab in real world setting in France. Patients will be invited to participate if initiating treatment with dupilumab for AD according to French-specific prescribing information. The decision of initiation of the treatment is independent to the study's participation. The study will be conducted in approximately 50 centers in France to evaluate a representative sample of patients treated in France. At each participating site, all AD participants who receive an initial prescription for dupilumab will be invited to participate in this study, until the enrollment goal is achieved.

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

入选标准

  • Male or female, 6 years or older.
  • Initiating treatment with dupilumab for AD according to French-specific prescribing information (≥ 12 years old: moderate to severe AD versus 6-11 years old: severe AD). The decision of initiation of the treatment is independent to the study's participation.
  • Able to understand and complete study-related questionnaires.
  • Signed informed consent form. For participants <18 years old, Informed consent form signed by the parent/legal guardian and participant's assent obtained.

排除标准

  • Patients who have a contraindication to the drug according to the French-specific prescribing information label.
  • 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.
  • Patients currently participating in any interventional clinical trial.
  • Patients previously treated with dupilumab.
  • Patients under tutorship or curatorship; patients under safeguard of justice or deprived of his/her liberty by an administrative or court decision.

研究组 & 干预措施

Participants with AD treated with dupilumab

Patients ≥6 years of age in whom dupilumab therapy was initiated to treat their AD according to French-specific prescribing information.

干预措施: Dupilumab (Drug)

结局指标

主要结局

Atopic comorbidities and treatments change from baseline

时间窗: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Demographic characteristics of participants who receive dupilumab for AD

时间窗: At baseline

Including age, gender, educational level, socio-professional category

Weight characteristics of participants who receive dupilumab for AD

时间窗: At baseline

Comorbidities and treatments change from baseline

时间窗: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in lifestyle habits of participants who receive dupilumab for AD

时间窗: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36 if applicable

Including alcohol, tobacco, CBD and cannabis consumption

Change from baseline in dupilumab dose

时间窗: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change in patient's treatment satisfaction score using the Patient Global Assessment of Treatment Effect (PGATE)

时间窗: At month 6, month 12, month 18, month 24, month 30, month 36

PGATE for patients ≥ 12 years of age: an internally developed and validated instrument allowing patients to rate their opinion and perceived treatment effect. Ratings are on a 5-point Likert scale from 1 being "Poor" and 5 being "Excellent".

Change in eczema severity using the Eczema Area and Severity Index (EASI)

时间窗: At baseline, month 6, month 12, month 18, month 24, month 30, month 36

EASI is a validated measure used to assess severity and extent of AD at each body region by multiplying the lesions characteristics score x the body area score x multiplier. Four AD disease characteristics -erythema, thickness (induration, population, and oedema), scratching (excoriation), and lichenification - will each be assessed for severity by the observing physician, as follows: 0 = none, absent; 1=mild (just perceptible); 2=Moderate (obvious); 3=Severe. The area score ranges from 0 to 6 is determined as follows: 0= 0% (no active eczema in region); 1= 1-9%; 2= 10-29%; 3= 30-49%; 4= 50-69%; 5= 70-89%; 6= 90-100% (entire region affected by eczema). The multiplier is determined according to the region affected and the age of the patient: 0.1 or 0.2 for patients \< 8 years old (head/neck), 0.2 (upper limbs), 0.3 (trunk), 0.4 or 0.3 for patients \< 8 years old (lower limbs). A higher score means higher AD severity. Scores range from 0 (no disease) to 72 (maximal disease severity).

Change in AD disease control using the Atopic Dermatitis Control Tool (ADCT)

时间窗: At baseline, month 6, month 12, month 18, month 24, month 30, month 36

ADCT for patients aged ≥ 12 years of age: a validated, brief and easily scored tool consisting of six concise questions allowing to rate the different dimensions of patient-perceived AD control, to foster communication between patients and their physicians and help appropriate decision-making. The instrument includes 6 items, with a 7-day recall period: overall severity of symptoms, frequency of intense episodes of itching, severity of bother, frequency of sleep impact, severity of daily activities impact and severity of mood or emotions impact. Each item is rated on a 5-point Likert scale, ranging from 0 (none/ not at all/ no nights) to 4 (very severe/ everyday/ extremely/ every night); the total score ranges from 0 to 24, which is the summation of the responses to all the items. A total score of ≥7 points was derived as the threshold to identify patients "not in control", based on optimal sensitivity/ specificity values. The higher the score, the less AD is controlled.

Height characteristics of participants who receive dupilumab for AD

时间窗: At baseline

Medical history characteristics of participants who receive dupilumab for AD

时间窗: At baseline

including previous treatments for AD, relevant medical history, family history of atopy

Change from baseline in dupilumab administration

时间窗: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in dupilumab compliance with treatment

时间窗: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in dupilumab temporary or permanent discontinuation

时间窗: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in dupilumab treatment switch to another therapy

时间窗: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in dupilumab treatment for concomitant AD treatments

时间窗: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change in itch assessment

时间窗: At baseline, month 6, month 12, month 18, month 24, month 30, month 36

Itch assessment (Worst-Itch Numeric Rating Scale, WI-NRS) will be rated from 0 to 10 on average during the past 7 days (adult, pediatric and adolescent patients), completed by the observing physician after questioning of patient; 0 = no itch and 10 = the worst imaginable itch.

Change in sleep disturbance NRS

时间窗: At baseline, month 6, month 12, month 18, month 24, month 30, month 36

NRS sleep disturbance will be rated from 0 to 10 on average during the past 7 days (adult, pediatric and adolescent patients), completed by the observing physician after questioning of patient; 0 = "sleep not disturbed at all" (best possible sleep) and 10 = "sleep extremely disturbed (worst possible sleep)".

Change in global patient's disease evaluation using the Patient Global Assessment of Disease Severity (PGADS)

时间窗: At baseline, month 6, month 12, month 18, month 24, month 30, month 36

PGADS for patients ≥ 12 years of age: an internally developed and validated instrument allowing to the patients to rate their AD-related overall well-being. Patients will be asked: "Considering all the ways in which your eczema affects you, how well are you doing?" Response choices will be from 1 being "Poor" to 5 being "Excellent".

Change in global patient's disease evaluation using the Caregiver Global Assessment of Disease (CGAD)

时间窗: At baseline, month 6, month 12, month 18, month 24, month 30, month 36

CGAD for patients 6 to 11 years of age: an internally developed and validated instrument allowing to the caregivers to rate their child's AD-related overall well-being. Caregivers will be asked: "Considering all the way in which the eczema affects your child, how well is your child doing?". Response choices will be 1 being "Poor" to 5 being "Excellent".

Change in Dermatology Life Quality Index (DLQI)

时间窗: At baseline, month 6, month 12, month 18, month 24, month 30, month 36

DLQI for patients ≥ 16 years (or cDLQI for patients \< 16 at baseline) are 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life in adults and pediatrics, respectively. The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 items, which assess quality of life over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor quality of life. Patients 6-11 years old will be assisted for questionnaire completion. A cDLQI's cartoon version could be also used for patients from 6 to 11 years old. If a patient turns 16 years old during the study, they will switch to DLQI.

Change in Dermatitis Family Impact Questionnaire (DFI)

时间窗: At baseline, month 6, month 12, month 18, month 24, month 30, month 36

DFI is a 10-item, validated questionnaire assessing the impact of AD on the QoL of the parents/legal representatives and family members of affected children. The format is a simple response (0 to 3 where 0 is "not at all" and 3 is "very much") to 10 items, which assess Quality of Life (QoL) over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QoL. It is designed to be completed by adults (aged 16 years or over) who have a child (up to and including the age of 15 years 11 months) in the family with atopic dermatitis.

Change in European Quality of Life-5 Dimensions-3 level score (EQ-5D-3L)

时间窗: At baseline, month 6, month 12, month 18, month 24, month 30, month 36

The EQ-5D-3L is completed by patients≥18 years old and by parent/legal representative of patients\<18 years old. It consists of 2 parts: * The EQ-5D descriptive system has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 3 levels: no problems, some problems, and extreme problems. The patient selects the most appropriate statement in each of the five dimensions, resulting in a 1-digit number for each dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. * The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scale is numbered 0 to 100. A higher value represents better health and a lower value represents worse health.

Change in Work Productivity and Activity Impairment Questionnaire, Atopic Dermatitis (WPAI-AD)

时间窗: At month 6, month 12, month 18, month 24, month 30, month 36

WPAI-AD for adults and WPAI-CIQ-AD for adolescents is a questionnaire designed to assess the impact of AD on the patient's productivity. The WPAI-AD is the version of the original generic WPAI that is specific to AD. It is a 6-item, validated questionnaire to measure impairments in work and activities over a 7-day recall period. The WPAI-AD outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. If a patient turns 18 years old during the study, this one will switch to WPAI-AD.

Number of Adverse Events (AE)

时间窗: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

AEs for dupilumab and/or concomitant treatments will be collected throughout the study.

Change from baseline in Drug Survival

时间窗: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

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

未报告次要终点

研究者

发起方
Sanofi
申办方类型
Industry
责任方
Sponsor

研究点 (42)

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