Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)

N/AActive Not RecruitingNCT03428646

Regeneron Pharmaceuticals858 enrolled

Overview

A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)

This is a prospective observational study conducted to (1) characterize the patients who receive DUPIXENT® for AD in a real world setting with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD; (2) characterize real world use patterns of DUPIXENT® for AD (eg, most commonly used regimens by line of therapy, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching); (3) assess the long-term effectiveness of DUPIXENT® in AD patients in a real world setting; (4) assess comorbid atopic conditions, patterns of use and effects of treatment in comorbid atopic conditions in patients who receive DUPIXENT® for AD; and (5) collect safety data on study participants

Study Type

OBSERVATIONAL

Enrollment

858

Conditions

Dermatitis, Atopic

Interventions

DupilumabDRUG

Dupixent 1 dose at Baseline required for eligibility; otherwise, no therapeutic intervention required during the course of the study. In addition to (or substituting for) DUPIXENT®, participants may receive marketed drugs as deemed necessary by their physicians for the treatment of AD or comorbid conditions.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Male or female, 12 years of age or older at the baseline visit. NOTE: Adolescent patients (at least 12 years old, but less than 18 years) are eligible in the US or Canada only after DUPIXENT receives the respective country's regulatory approval for use in this age group. * Initiating treatment with DUPIXENT® as standard-of-care for AD according to the country-specific prescribing information (Note: Participants will be screened when they received their initial prescription for DUPIXENT®). * Willing and able to comply with study-related activities. * Able to understand and complete study-related questionnaires. * Provide signed informed consent or parental/legal guardian consent plus patient assent, where applicable. Key Exclusion Criteria: * Patients who have a contraindication to the drug according to the country-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 co-morbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments. * Prior use of dupilumab within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Locations (99)

Outcomes

Primary Outcomes

Registry Assessment: Baseline Characteristics

Medical history

Time frame: At baseline (day when DUPIXENT treatment is initiated)

Registry Assessment: Baseline Characteristic

Socio-demographics

Time frame: At baseline (day when DUPIXENT treatment is initiated)

Secondary Outcomes

Registry (Physician) Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis

Percentage of BSA affected by AD assessed for each major section of the body

Time frame: Baseline to month 60

Registry (Physician) Assessment: Eczema Area and Severity Index (EASI)

Measure used in clinical practice and clinical trials to assess the severity and extent of AD

Time frame: Baseline to month 60

Registry (Physician) Assessment: Overall Disease Severity scale

Questionnaire used to characterizing the severity of AD on a 4-point scale (0=No disease, 1=Minimal disease, 2=Mild disease, 3=Moderate disease, 4=Severe disease)

Time frame: Baseline to month 60

Registry (Participant) Assessment: Patient Oriented Eczema Measure

Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults

Time frame: Baseline to month 60

Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS)

Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale.

Time frame: Baseline to month 60

Data from ClinicalTrials.gov

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Regeneron Investigational Site

Birmingham, Alabama, United States

Regeneron Investigational Site

Gilbert, Arizona, United States

Regeneron Investigational Site

Fountain Valley, California, United States

Regeneron Investigational Site

Laguna Hills, California, United States

Regeneron Investigational Site

Loma Linda, California, United States

Regeneron Investigational Site

Los Angeles, California, United States

Regeneron Investigational Site

Los Angeles, California, United States

Regeneron Investigational Site

Manhattan Beach, California, United States

Regeneron Investigational Site

Newport Beach, California, United States

Regeneron Investigational Site

Oceanside, California, United States

...and 89 more locations

Registry (Participant) Assessment: Skin Pain or Soreness NRS

Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS

Time frame: Baseline to month 60

Registry (Participant) Assessment: Skin Feeling Hot NRS

Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS

Time frame: Baseline to month 60

Registry (Participant) Assessment: Skin Sensitivity NRS

Individual NRS used to rate skin sensitivity using a 0 to 10 NRS

Time frame: Baseline to month 60

Registry (Participant) Assessment: Sleep Disturbance NRS

Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS

Time frame: Baseline to month 60

Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale

Rate of overall well-being on a 5-point scale.

Time frame: Baseline to month 60

Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI)

Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) in adults

Time frame: Baseline to month 60

Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI)

Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on QOL in pediatrics.

Time frame: Baseline to month 60

Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD)

Questionnaire to assess the impact of AD on productivity.

Time frame: Baseline to month 60

Registry (Participant) Assessment: Health Care Resource Utilization Questionnaire

Questionnaire regarding hospitalization, or emergency room/ urgent care center visits due to AD.

Time frame: Baseline to month 60

Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire

Questionnaire to assess the impact of atopic eczema on the QOL of the parents and family members of affected children.

Time frame: Baseline to month 60

Registry (Participant) Assessment: Missed School Days

Questionnaire to assess the number of missed school days since the last study assessment of adolescent patients (aged ≥ 12 to \< 18 years) who are enrolled in school.

Time frame: Baseline to month 60

Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5)

5-question version of questionnaire to evaluate asthma control in registry patients with comorbid asthma.

Time frame: Baseline to month 60

Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS)

Questionnaire used as a validated measuring instrument for the documentation of symptoms and therapy monitoring in AR.

Time frame: Baseline to month 60

Registry (Participant) Assessment: Changes in Concurrent Conditions

Rate of change in any other condition(s) (other than eczema, asthma, and allergic symptoms) on a 2-point scale (Better or Worse).

Time frame: Baseline to month 60

Registry (Participant) Assessment: Overall Health State

Rate of overall state of health on a 5-point scale (Poor, Fair, Good, Very Good or Excellent).

Time frame: Baseline to month 60