Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)
- Registration Number
- NCT03992417
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 955
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with AD Dupilumab SAR231893 (REGN668) Adult and adolescent participants with AD initiating treatment with Dupixent® for AD according to the country-specific prescribing information, as part of their usual care as determined by their physician
- Primary Outcome Measures
Name Time Method Baseline Characteristics: Medical history Baseline to Month 60 Baseline Characteristics: Socio-demographics Baseline to Month 60 Baseline Characteristics: Disease characteristics Baseline to Month 60
- Secondary Outcome Measures
Name Time Method Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis Baseline to Month 60 Percentage of BSA affected by AD assessed for each major section of the body
Physician Assessment: Eczema Area and Severity Index (EASI) Baseline to Month 60 Measure used in clinical practice and clinical trials to assess the severity and extent of AD
Physician Assessment: Scoring of Atopic Dermatitis (SCORAD) Baseline to Month 60 Measure used in clinical practice and clinical trials to standardize the evaluation of the severity and extent of AD
Participant Assessment: Patient Oriented Eczema Measure (POEM) Baseline to Month 60 Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults
Participant Assessment: Pruritus Numerical Rating Scale (NRS) Baseline to Month 60 Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale
Participant Assessment: Skin Pain or Soreness NRS Baseline to Month 60 Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS
Participant Assessment: Skin Feeling Hot NRS Baseline to Month 60 Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS
Participant Assessment: Skin Sensitivity NRS Baseline to Month 60 Individual NRS used to rate skin sensitivity using a 0 to 10 NRS
Participant Assessment: Sleep Disturbance NRS Baseline to Month 60 Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS
Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents Baseline to Month 60 Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL)
Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5) Baseline to Month 60 Questionnaire to evaluate asthma control in participants with comorbid asthma
Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS) Baseline to Month 60 Instrument for the documentation of symptoms and therapy monitoring in allergic rhinitis
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 Baseline to Month 60 Questionnaire to assess the impact of AD on productivity
Participant Assessment: Health Care Resource Utilization Questionnaire Baseline to Month 60 Questionnaire regarding hospitalization, or emergency room/urgent care center visits due to AD
Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9) Baseline to Month 60 Instrument to measure treatment satisfaction
Adverse events (AEs) Baseline to Month 60 Number of participants with at least 1 AE
Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally Baseline to Month 60 Questionnaire related with Atopic dermatitis control
Trial Locations
- Locations (114)
Investigational Site Number : 0560010
🇧🇪Gent, Belgium
Investigational Site Number : 1700008
🇨🇴Bogota, Colombia
Investigational Site Number : 0560004
🇧🇪Namur, Belgium
Investigational Site Number : 1700011
🇨🇴Medellín, Colombia
Investigational Site Number : 2030003
🇨🇿Ostrava - Poruba, Czechia
Investigational Site Number : 0560003
🇧🇪Jette, Belgium
Investigational Site Number : 0560006
🇧🇪Roeselare, Belgium
Investigational Site Number : 2030006
🇨🇿Olomouc, Czechia
Investigational Site Number : 0560008
🇧🇪Leuven, Belgium
Investigational Site Number : 2030005
🇨🇿Praha 1, Czechia
Investigational Site Number : 2030008
🇨🇿Hradec Kralove, Czechia
Investigational Site Number : 2030004
🇨🇿Plzen, Czechia
Investigational Site Number : 2030002
🇨🇿Praha 5, Czechia
Investigational Site Number : 7240001
🇪🇸Madrid, Spain
Investigational Site Number : 3920010
🇯🇵Setagaya-ku, Japan
Investigational Site Number : 2500006
🇫🇷Pierre Benite cedex, France
Investigational Site Number : 3000003
🇬🇷Thessaloniki, Greece
Investigational Site Number : 2500005
🇫🇷Saint-Mandé Cedex, France
Investigational Site Number : 3920022
🇯🇵Amagasaki-shi, Japan
Investigational Site Number : 3920002
🇯🇵Habikino-shi, Japan
Investigational Site Number : 3000001
🇬🇷Thessaloniki, Greece
Investigational Site Number : 2500001
🇫🇷Valence, France
Investigational Site Number : 5280002
🇳🇱Bergen op Zoom, Netherlands
Investigational Site Number : 3920013
🇯🇵Marugame-shi, Japan
Investigational Site Number : 3920014
🇯🇵Hamamatsu-shi, Japan
Investigational Site Number : 3760001
🇮🇱Haifa, Israel
Investigational Site Number : 3920020
🇯🇵Yokohama-shi, Japan
Investigational Site Number : 3760005
🇮🇱Haifa, Israel
Investigational Site Number : 3920012
🇯🇵Minokamo-shi, Japan
Investigational Site Number : 3920003
🇯🇵Itabashi-ku, Tokyo, Japan
Investigational Site Number : 7240016
🇪🇸Madrid, Spain
Investigational Site Number : 7240009
🇪🇸Barcelona, Spain
Investigational Site Number : 5780002
🇳🇴Bergen, Norway
Investigational Site Number : 1580011
🇨🇳Taichung, Taiwan
Investigational Site Number : 7240008
🇪🇸Santiago de Compostela, Spain
Investigational Site Number : 7240007
🇪🇸Madrid, Spain
Investigational Site Number : 3920001
🇯🇵Nagoya-shi, Japan
Investigational Site Number : 1580015
🇨🇳Taoyuan County, Taiwan
Investigational Site Number : 7240010
🇪🇸Madrid, Spain
Investigational Site Number : 7240014
🇪🇸Barcelona, Spain
Investigational Site Number : 7240019
🇪🇸Bilbao, Bizkaia, Spain
Investigational Site Number : 4140001
🇰🇼Sulaibikat, Kuwait
Investigational Site Number : 6200004
🇵🇹Porto, Portugal
Investigational Site Number : 1580014
🇨🇳Taipei, Taiwan
Investigational Site Number : 0400005
🇦🇹Graz, Austria
Investigational Site Number : 0360001
🇦🇺Carlton, Victoria, Australia
Investigational Site Number : 0320013
🇦🇷Pilar, Buenos Aires, Argentina
Investigational Site Number : 3000002
🇬🇷Athens, Greece
Investigational Site Number : 5780001
🇳🇴Bodø, Norway
Investigational Site Number : 1580012
🇨🇳Kaohsiung, Taiwan
Investigational Site Number : 7240004
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain
Investigational Site Number : 6200001
🇵🇹Vila Nova de Gaia, Portugal
Investigational Site Number : 6820001
🇸🇦Jeddah, Saudi Arabia
Investigational Site Number : 4840001
🇲🇽Guadalajara, Jalisco, Mexico
Investigational Site Number : 7240002
🇪🇸Oviedo, Asturias, Spain
Investigational Site Number : 6200003
🇵🇹Coimbra, Portugal
Investigational Site Number : 6430004
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number : 7240011
🇪🇸Santullano De Mieres, Asturias, Spain
Investigational Site Number : 6200002
🇵🇹Lisboa, Portugal
Investigational Site Number : 3800007
🇮🇹Brescia, Italy
Investigational Site Number : 3800016
🇮🇹Torino, Italy
Investigational Site Number : 0320012
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number : 0360002
🇦🇺Kogarah, New South Wales, Australia
Investigational Site Number : 0320011
🇦🇷Ciudad Autonoma Bs As, Argentina
Investigational Site Number : 0360005
🇦🇺Kogarah, New South Wales, Australia
Investigational Site Number : 0360003
🇦🇺Woolloongabba, Queensland, Australia
Investigational Site Number : 0400004
🇦🇹Linz, Austria
Investigational Site Number : 0400002
🇦🇹Maria Enzersdorf, Austria
Investigational Site Number : 0400001
🇦🇹Vienna, Austria
Investigational Site Number : 0560002
🇧🇪Brussels, Belgium
Investigational Site Number : 0560007
🇧🇪Edegem, Belgium
Investigational Site Number : 0560001
🇧🇪Leige, Belgium
Investigational Site Number : 1700012
🇨🇴Bogota, Colombia
Investigational Site Number : 2460002
🇫🇮Kokkola, Finland
Investigational Site Number : 2030001
🇨🇿Usti nad Labem, Czechia
Investigational Site Number : 2500004
🇫🇷Auxerre, France
Investigational Site Number : 2500011
🇫🇷Antony, France
Investigational Site Number : 2500003
🇫🇷Bordeaux, France
Investigational Site Number : 2500010
🇫🇷Rouen, France
Investigational Site Number : 2500009
🇫🇷Montpellier Cedex 5, France
Investigational Site Number : 2500002
🇫🇷Toulouse Cedex 9, France
Investigational Site Number : 3760006
🇮🇱Afula, Israel
Investigational Site Number : 3760002
🇮🇱Jerusalem, Israel
Investigational Site Number : 3760004
🇮🇱Ramat Gan, Israel
Investigational Site Number : 3760003
🇮🇱Rehovot, Israel
Investigational Site Number : 3800009
🇮🇹Torrette Di Ancona, Ancona, Italy
Investigational Site Number : 3800003
🇮🇹Rome, Roma, Italy
Investigational Site Number : 3800017
🇮🇹Terracina, Latina, Italy
Investigational Site Number : 3800012
🇮🇹Bari, Italy
Investigational Site Number : 3800011
🇮🇹Rome, Roma, Italy
Investigational Site Number : 3800015
🇮🇹L'Aquila, Italy
Investigational Site Number : 3800008
🇮🇹Genova, Italy
Investigational Site Number : 3800013
🇮🇹Cagliari, Italy
Investigational Site Number : 3800001
🇮🇹Napoli, Italy
Investigational Site Number : 3800004
🇮🇹Milano, Italy
Investigational Site Number : 3800005
🇮🇹Roma, Italy
Investigational Site Number : 3800018
🇮🇹Palermo, Italy
Investigational Site Number : 3920004
🇯🇵Nagakute-shi, Aichi, Japan
Investigational Site Number : 3800010
🇮🇹Pisa, Italy
Investigational Site Number : 3920008
🇯🇵Koshigaya-shi, Saitama, Japan
Investigational Site Number : 3920006
🇯🇵Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920015
🇯🇵Obihiro-shi, Hokkaido, Japan
Investigational Site Number : 3920011
🇯🇵Hirakata-shi, Osaka, Japan
Investigational Site Number : 3920005
🇯🇵Shimotsuga-gun, Tochigi, Japan
Investigational Site Number : 3920025
🇯🇵Kyoto-shi, Japan
Investigational Site Number : 6820013
🇸🇦Dammam, Saudi Arabia
Investigational Site Number : 7240012
🇪🇸Majadahonda, Madrid, Spain
Investigational Site Number : 7240017
🇪🇸Baracaldo, Spain
Investigational Site Number : 7240021
🇪🇸Granada, Spain
Investigational Site Number : 7240006
🇪🇸Madrid, Spain
Investigational Site Number : 7840002
🇦🇪Al Ain, United Arab Emirates
Investigational Site Number : 6430001
🇷🇺Moscow, Russian Federation
Investigational Site Number : 6430002
🇷🇺Moscow, Russian Federation
Investigational Site Number : 0360004
🇦🇺Bedford Park, South Australia, Australia