Clinical trial NCT03992417: Observational 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
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2019-06-20
Enrollment: 955
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 is 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: Primary Objective:

To characterize the patients who receive Dupixent® (dupilumab) 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

Secondary Objectives:

* To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching)
* To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting
* To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD
* To collect safety data on study participants

Detailed description: Participants enrolled in the study will be followed for 5 years.

Eligibility criteria: Inclusion Criteria:

* Male or female, 12 years or older at the baseline visit. Note: Adolescent participants (at least 12 years old, but less than 18 years) are eligible only after Dupixent® receives the respective country's regulatory approval for use in this age group;
* Initiating treatment with Dupixent® for AD according to the country-specific prescribing information. Note: Participants may be eligible if they have already initiated treatment with Dupixent® for AD within 6 months before their enrollment in the registry, provided that all core baseline data required (Eczema Area and Severity Index \[EASI\], Scoring of Atopic Dermatitis \[SCORAD\], body surface area \[of AD involvement\] \[BSA\], Patient-Oriented Eczema Measure \[POEM\], and Dermatology Life Quality Index \[DLQI\]) by the registry protocol were captured at the time of initiating Dupixent® treatment and are available for entry in the registry database
* Able to understand and complete study-related questionnaires
* Provide signed informed consent or parental/legally acceptable representative consent and/or patient assent where applicable

Exclusion Criteria:

* Participants 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 participant patient from adequately completing the schedule of visits and assessments
* Patients currently participating in any interventional clinical trial which modifies patient care
* Prior use of Dupixent® within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Baseline Characteristics: Medical history
timeFrame: Baseline to Month 60
measure: Baseline Characteristics: Socio-demographics
timeFrame: Baseline to Month 60
measure: Baseline Characteristics: Disease characteristics
timeFrame: Baseline to Month 60
Secondary outcomes:
measure: Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis
timeFrame: Baseline to Month 60
measure: Physician Assessment: Eczema Area and Severity Index (EASI)
timeFrame: Baseline to Month 60
measure: Physician Assessment: Scoring of Atopic Dermatitis (SCORAD)
timeFrame: Baseline to Month 60
measure: Participant Assessment: Patient Oriented Eczema Measure (POEM)
timeFrame: Baseline to Month 60
measure: Participant Assessment: Pruritus Numerical Rating Scale (NRS)
timeFrame: Baseline to Month 60
measure: Participant Assessment: Skin Pain or Soreness NRS
timeFrame: Baseline to Month 60
measure: Participant Assessment: Skin Feeling Hot NRS
timeFrame: Baseline to Month 60
measure: Participant Assessment: Skin Sensitivity NRS
timeFrame: Baseline to Month 60
measure: Participant Assessment: Sleep Disturbance NRS
timeFrame: Baseline to Month 60
measure: Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents
timeFrame: Baseline to Month 60
measure: Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5)
timeFrame: Baseline to Month 60
measure: Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS)
timeFrame: Baseline to Month 60
measure: Participant Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) for adults and Work Productivity and Activity Impairment Questionnaire+Classroom Impairment Questions for AD (WPAI-CIQ-AD) for adolescents
timeFrame: Baseline to Month 60
measure: Participant Assessment: Health Care Resource Utilization Questionnaire
timeFrame: Baseline to Month 60
measure: Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9)
timeFrame: Baseline to Month 60
measure: Adverse events (AEs)
timeFrame: Baseline to Month 60
measure: Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally
timeFrame: Baseline to Month 60
Other outcomes:
Locations:
city: Pilar
country: Argentina
facility: Investigational Site Number : 0320013
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320012
state: Santa Fe
city: Ciudad Autonoma Bs As
country: Argentina
facility: Investigational Site Number : 0320011
city: Kogarah
country: Australia
facility: Investigational Site Number : 0360002
state: New South Wales
city: Kogarah
country: Australia
facility: Investigational Site Number : 0360005
state: New South Wales
city: Woolloongabba
country: Australia
facility: Investigational Site Number : 0360003
state: Queensland
city: Bedford Park
country: Australia
facility: Investigational Site Number : 0360004
state: South Australia
city: Carlton
country: Australia
facility: Investigational Site Number : 0360001
state: Victoria
city: Graz
country: Austria
facility: Investigational Site Number : 0400005
city: Linz
country: Austria
facility: Investigational Site Number : 0400004
city: Maria Enzersdorf
country: Austria
facility: Investigational Site Number : 0400002
city: Vienna
country: Austria
facility: Investigational Site Number : 0400001
city: Brussels
country: Belgium
facility: Investigational Site Number : 0560002
city: Edegem
country: Belgium
facility: Investigational Site Number : 0560007
city: Gent
country: Belgium
facility: Investigational Site Number : 0560010
city: Jette
country: Belgium
facility: Investigational Site Number : 0560003
city: Leige
country: Belgium
facility: Investigational Site Number : 0560001
city: Leuven
country: Belgium
facility: Investigational Site Number : 0560008
city: Namur
country: Belgium
facility: Investigational Site Number : 0560004
city: Roeselare
country: Belgium
facility: Investigational Site Number : 0560006
city: Bogota
country: Colombia
facility: Investigational Site Number : 1700008
city: Bogota
country: Colombia
facility: Investigational Site Number : 1700012
city: Medellín
country: Colombia
facility: Investigational Site Number : 1700011
city: Hradec Kralove
country: Czechia
facility: Investigational Site Number : 2030008
city: Olomouc
country: Czechia
facility: Investigational Site Number : 2030006
city: Ostrava - Poruba
country: Czechia
facility: Investigational Site Number : 2030003
city: Plzen
country: Czechia
facility: Investigational Site Number : 2030004
city: Praha 1
country: Czechia
facility: Investigational Site Number : 2030005
city: Praha 5
country: Czechia
facility: Investigational Site Number : 2030002
city: Usti nad Labem
country: Czechia
facility: Investigational Site Number : 2030001
city: Kokkola
country: Finland
facility: Investigational Site Number : 2460002
city: Antony
country: France
facility: Investigational Site Number : 2500011
city: Auxerre
country: France
facility: Investigational Site Number : 2500004
city: Bordeaux
country: France
facility: Investigational Site Number : 2500003
city: Montpellier Cedex 5
country: France
facility: Investigational Site Number : 2500009
city: Pierre Benite cedex
country: France
facility: Investigational Site Number : 2500006
city: Rouen
country: France
facility: Investigational Site Number : 2500010
city: Saint-MandÃ© Cedex
country: France
facility: Investigational Site Number : 2500005
city: Toulouse Cedex 9
country: France
facility: Investigational Site Number : 2500002
city: Valence
country: France
facility: Investigational Site Number : 2500001
city: Athens
country: Greece
facility: Investigational Site Number : 3000002
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000003
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000001
city: Afula
country: Israel
facility: Investigational Site Number : 3760006
city: Haifa
country: Israel
facility: Investigational Site Number : 3760005
city: Haifa
country: Israel
facility: Investigational Site Number : 3760001
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760002
city: Ramat Gan
country: Israel
facility: Investigational Site Number : 3760004
city: Rehovot
country: Israel
facility: Investigational Site Number : 3760003
city: Torrette Di Ancona
country: Italy
facility: Investigational Site Number : 3800009
state: Ancona
city: Terracina
country: Italy
facility: Investigational Site Number : 3800017
state: Latina
city: Rome
country: Italy
facility: Investigational Site Number : 3800003
state: Roma
city: Rome
country: Italy
facility: Investigational Site Number : 3800011
state: Roma
city: Bari
country: Italy
facility: Investigational Site Number : 3800012
city: Brescia
country: Italy
facility: Investigational Site Number : 3800007
city: Cagliari
country: Italy
facility: Investigational Site Number : 3800013
city: Genova
country: Italy
facility: Investigational Site Number : 3800008
city: L'Aquila
country: Italy
facility: Investigational Site Number : 3800015
city: Milano
country: Italy
facility: Investigational Site Number : 3800004
city: Napoli
country: Italy
facility: Investigational Site Number : 3800001
city: Palermo
country: Italy
facility: Investigational Site Number : 3800018
city: Pisa
country: Italy
facility: Investigational Site Number : 3800010
city: Roma
country: Italy
facility: Investigational Site Number : 3800005
city: Torino
country: Italy
facility: Investigational Site Number : 3800016
city: Nagakute-shi
country: Japan
facility: Investigational Site Number : 3920004
state: Aichi
city: Obihiro-shi
country: Japan
facility: Investigational Site Number : 3920015
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Investigational Site Number : 3920006
state: Hokkaido
city: Hirakata-shi
country: Japan
facility: Investigational Site Number : 3920011
state: Osaka
city: Koshigaya-shi
country: Japan
facility: Investigational Site Number : 3920008
state: Saitama
city: Shimotsuga-gun
country: Japan
facility: Investigational Site Number : 3920005
state: Tochigi
city: Itabashi-ku
country: Japan
facility: Investigational Site Number : 3920003
state: Tokyo
city: Amagasaki-shi
country: Japan
facility: Investigational Site Number : 3920022
city: Habikino-shi
country: Japan
facility: Investigational Site Number : 3920002
city: Hamamatsu-shi
country: Japan
facility: Investigational Site Number : 3920014
city: Kyoto-shi
country: Japan
facility: Investigational Site Number : 3920025
city: Marugame-shi
country: Japan
facility: Investigational Site Number : 3920013
city: Minokamo-shi
country: Japan
facility: Investigational Site Number : 3920012
city: Nagoya-shi
country: Japan
facility: Investigational Site Number : 3920001
city: Setagaya-ku
country: Japan
facility: Investigational Site Number : 3920010
city: Yokohama-shi
country: Japan
facility: Investigational Site Number : 3920020
city: Sulaibikat
country: Kuwait
facility: Investigational Site Number : 4140001
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4840001
state: Jalisco
city: Bergen op Zoom
country: Netherlands
facility: Investigational Site Number : 5280002
city: Bergen
country: Norway
facility: Investigational Site Number : 5780002
city: BodÃ¸
country: Norway
facility: Investigational Site Number : 5780001
city: Coimbra
country: Portugal
facility: Investigational Site Number : 6200003
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200002
city: Porto
country: Portugal
facility: Investigational Site Number : 6200004
city: Vila Nova de Gaia
country: Portugal
facility: Investigational Site Number : 6200001
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430001
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430002
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430004
city: Dammam
country: Saudi Arabia
facility: Investigational Site Number : 6820013
city: Jeddah
country: Saudi Arabia
facility: Investigational Site Number : 6820001
city: Oviedo
country: Spain
facility: Investigational Site Number : 7240002
state: Asturias
city: Santullano De Mieres
country: Spain
facility: Investigational Site Number : 7240011
state: Asturias
city: Bilbao
country: Spain
facility: Investigational Site Number : 7240019
state: Bizkaia
city: Las Palmas de Gran Canaria
country: Spain
facility: Investigational Site Number : 7240004
state: Las Palmas
city: Majadahonda
country: Spain
facility: Investigational Site Number : 7240012
state: Madrid
city: Baracaldo
country: Spain
facility: Investigational Site Number : 7240017
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240009
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240014
city: Granada
country: Spain
facility: Investigational Site Number : 7240021
city: Madrid
country: Spain
facility: Investigational Site Number : 7240016
city: Madrid
country: Spain
facility: Investigational Site Number : 7240007
city: Madrid
country: Spain
facility: Investigational Site Number : 7240006
city: Madrid
country: Spain
facility: Investigational Site Number : 7240010
city: Madrid
country: Spain
facility: Investigational Site Number : 7240001
city: Santiago de Compostela
country: Spain
facility: Investigational Site Number : 7240008
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number : 1580012
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1580011
city: Taipei
country: Taiwan
facility: Investigational Site Number : 1580014
city: Taoyuan County
country: Taiwan
facility: Investigational Site Number : 1580015
city: Al Ain
country: United Arab Emirates
facility: Investigational Site Number : 7840002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: