Clinical trial NCT03428646: Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)
Official title: A Prospective Observational Study of Patients Receiving DUPIXENT® for Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dermatitis, Atopic
Keywords: Eczema
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2018-02-09
Enrollment: 858
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population comprises adult and adolescent patients (male or female, ≥12 years old), who are initiating treatment with DUPIXENT® for AD according to the country-specific prescribing information.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Registry Assessment: Baseline Characteristics
timeFrame: At baseline (day when DUPIXENT treatment is initiated)
measure: Registry Assessment: Baseline Characteristic
timeFrame: At baseline (day when DUPIXENT treatment is initiated)
Secondary outcomes:
measure: Registry (Physician) Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis
timeFrame: Baseline to month 60
measure: Registry (Physician) Assessment: Eczema Area and Severity Index (EASI)
timeFrame: Baseline to month 60
measure: Registry (Physician) Assessment: Overall Disease Severity scale
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Patient Oriented Eczema Measure
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS)
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Skin Pain or Soreness NRS
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Skin Feeling Hot NRS
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Skin Sensitivity NRS
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Sleep Disturbance NRS
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI)
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD)
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Health Care Resource Utilization Questionnaire
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Missed School Days
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5)
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS)
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Changes in Concurrent Conditions
timeFrame: Baseline to month 60
measure: Registry (Participant) Assessment: Overall Health State
timeFrame: Baseline to month 60
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Regeneron Investigational Site
state: Alabama
city: Gilbert
country: United States
facility: Regeneron Investigational Site
state: Arizona
city: Fountain Valley
country: United States
facility: Regeneron Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Regeneron Investigational Site
state: California
city: Loma Linda
country: United States
facility: Regeneron Investigational Site
state: California
city: Los Angeles
country: United States
facility: Regeneron Investigational Site
state: California
city: Los Angeles
country: United States
facility: Regeneron Investigational Site
state: California
city: Manhattan Beach
country: United States
facility: Regeneron Investigational Site
state: California
city: Newport Beach
country: United States
facility: Regeneron Investigational Site
state: California
city: Oceanside
country: United States
facility: Regeneron Investigational Site
state: California
city: Redondo Beach
country: United States
facility: Regeneron Investigational Site
state: California
city: Riverside
country: United States
facility: Regeneron Investigational Site
state: California
city: Roseville
country: United States
facility: Regeneron Investigational Site
state: California
city: San Diego
country: United States
facility: Regeneron Investigational Site
state: California
city: Santa Monica
country: United States
facility: Regeneron Investigational Site
state: California
city: Thousand Oaks
country: United States
facility: Regeneron Investigational Site
state: California
city: New Haven
country: United States
facility: Regeneron Investigational Site
state: Connecticut
city: Coral Gables
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Margate
country: United States
facility: Regeneron Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Regeneron Investigational Site
state: Georgia
city: Macon
country: United States
facility: Regeneron Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Regeneron Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Regeneron Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Regeneron Investigational Site
state: Georgia
city: Champaign
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: La Grange Park
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: Fort Wayne
country: United States
facility: Regeneron Investigational Site
state: Indiana
city: Plainfield
country: United States
facility: Regeneron Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Regeneron Investigational Site
state: Kansas
city: Corbin
country: United States
facility: Regeneron Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Regeneron Investigational Site
state: Kentucky
city: Rockville
country: United States
facility: Regeneron Investigational Site
state: Maryland
city: Towson
country: United States
facility: Regeneron Investigational Site
state: Maryland
city: Upper Marlboro
country: United States
facility: Regeneron Investigational Site
state: Maryland
city: White Marsh
country: United States
facility: Regeneron Investigational Site
state: Maryland
city: Quincy
country: United States
facility: Regeneron Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Regeneron Investigational Site
state: Michigan
city: Bay City
country: United States
facility: Regeneron Investigational Site
state: Michigan
city: Troy
country: United States
facility: Regeneron Investigational Site
state: Michigan
city: Warren
country: United States
facility: Regeneron Investigational Site
state: Michigan
city: Columbia
country: United States
facility: Regeneron Investigational Site
state: Missouri
city: Kirksville
country: United States
facility: Regeneron Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Regeneron Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Regeneron Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Regeneron Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Regeneron Investigational Site
state: Nevada
city: Brick
country: United States
facility: Regeneron Investigational Site
state: New Jersey
city: East Windsor
country: United States
facility: Regeneron Investigational Site
state: New Jersey
city: Edison
country: United States
facility: Regeneron Investigational Site
state: New Jersey
city: Piscataway
country: United States
facility: Regeneron Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: Regeneron Investigational Site
state: New York
city: Elmhurst
country: United States
facility: Regeneron Investigational Site
state: New York
city: Forest Hills
country: United States
facility: Regeneron Investigational Site
state: New York
city: Garden City
country: United States
facility: Regeneron Investigational Site
state: New York
city: Kew Gardens
country: United States
facility: Regeneron Investigational Site
state: New York
city: Lake Success
country: United States
facility: Regeneron Investigational Site
state: New York
city: Manhasset
country: United States
facility: Regeneron Investigational Site
state: New York
city: Mineola
country: United States
facility: Regeneron Investigational Site
state: New York
city: Mount Vernon
country: United States
facility: Regeneron Investigational Site
state: New York
city: New York
country: United States
facility: Regeneron Investigational Site
state: New York
city: New York
country: United States
facility: Regeneron Investigational Site
state: New York
city: New York
country: United States
facility: Regeneron Investigational Site
state: New York
city: New York
country: United States
facility: Regeneron Investigational Site
state: New York
city: Troy
country: United States
facility: Regeneron Investigational Site
state: New York
city: Concord
country: United States
facility: Regeneron Investigational Site
state: North Carolina
city: Akron
country: United States
facility: Regeneron Investigational Site
state: Ohio
city: Athens
country: United States
facility: Regeneron Investigational Site
state: Ohio
city: Bexley
country: United States
facility: Regeneron Investigational Site
state: Ohio
city: Marion
country: United States
facility: Regeneron Investigational Site
state: Ohio
city: Mason
country: United States
facility: Regeneron Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Regeneron Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Regeneron Investigational Site
state: Oregon
city: Blue Bell
country: United States
facility: Regeneron Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Regeneron Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Regeneron Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Regeneron Investigational Site
state: Pennsylvania
city: Yardley
country: United States
facility: Regeneron Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Regeneron Investigational Site
state: South Carolina
city: North Charleston
country: United States
facility: Regeneron Investigational Site
state: South Carolina
city: Bellaire
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Dallas
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Grapevine
country: United States
facility: Regeneron Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Arlington
country: United States
facility: Regeneron Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Regeneron Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: Regeneron Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Regeneron Investigational Site
state: Wisconsin
city: Hamilton
country: Canada
facility: Regeneron Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Regeneron Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Regeneron Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: Regeneron Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Regeneron Investigational Site
state: Ontario
city: Quebec
country: Canada
facility: Regeneron Investigational Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Medical Affairs
role: STUDY_DIRECTOR
References:
citation: Bagel J, Nguyen TQ, Lima H, Jain N, Pariser DM, Hsu S, Yosipovitch G, Zhang H, Chao J, Bansal S, Chen Z, Richman D, Korotzer A, Ardeleanu M. Baseline Demographics and Severity and Burden of Atopic Dermatitis in Adult Patients Initiating Dupilumab Treatment in a Real-World Registry (PROSE). Dermatol Ther (Heidelb). 2022 Jun;12(6):1417-1430. doi: 10.1007/s13555-022-00742-w. Epub 2022 May 20.