A Prospective Observational Study of Patients Receiving DUPIXENT® for Atopic Dermatitis

Regeneron Pharmaceuticals1 site in 1 country858 target enrollmentApril 6, 2018

ConditionsDermatitis, Atopic

DrugsDupilumab

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dermatitis, Atopic
Sponsor: Regeneron Pharmaceuticals
Enrollment: 858
Locations: 1
Primary Endpoint: Registry Assessment: Baseline Characteristics
Status: Active, not recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

April 6, 2018

End Date

March 30, 2027

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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.

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.

Outcomes

Primary Outcomes

Registry Assessment: Baseline Characteristics

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

Medical history

Registry Assessment: Baseline Characteristic

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

Socio-demographics

Secondary Outcomes

Registry (Physician) Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis(Baseline to month 60)
Registry (Physician) Assessment: Eczema Area and Severity Index (EASI)(Baseline to month 60)
Registry (Physician) Assessment: Overall Disease Severity scale(Baseline to month 60)
Registry (Participant) Assessment: Patient Oriented Eczema Measure(Baseline to month 60)
Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS)(Baseline to month 60)
Registry (Participant) Assessment: Skin Pain or Soreness NRS(Baseline to month 60)
Registry (Participant) Assessment: Skin Feeling Hot NRS(Baseline to month 60)
Registry (Participant) Assessment: Skin Sensitivity NRS(Baseline to month 60)
Registry (Participant) Assessment: Sleep Disturbance NRS(Baseline to month 60)
Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale(Baseline to month 60)
Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI)(Baseline to month 60)
Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD)(Baseline to month 60)
Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI)(Baseline to month 60)
Registry (Participant) Assessment: Health Care Resource Utilization Questionnaire(Baseline to month 60)
Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire(Baseline to month 60)
Registry (Participant) Assessment: Missed School Days(Baseline to month 60)
Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5)(Baseline to month 60)
Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS)(Baseline to month 60)
Registry (Participant) Assessment: Changes in Concurrent Conditions(Baseline to month 60)
Registry (Participant) Assessment: Overall Health State(Baseline to month 60)