Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD) (GLOBOSTAD)
A Prospective Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
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Ciudad Autonoma Bs As, Argentina, C1121ABE
- Investigational Site Number : 0320011
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Buenos Aires
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Pilar, Buenos Aires, Argentina, B1629ODT
- Investigational Site Number : 0320013
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000DBS
- Investigational Site Number : 0320012
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New South Wales
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Kogarah, New South Wales, Australia, 2217
- Investigational Site Number : 0360002
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Kogarah, New South Wales, Australia, 2217
- Investigational Site Number : 0360005
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Investigational Site Number : 0360003
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South Australia
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Bedford Park, South Australia, Australia, 5042
- Investigational Site Number : 0360004
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Victoria
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Carlton, Victoria, Australia, 3053
- Investigational Site Number : 0360001
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Graz, Austria, 8036
- Investigational Site Number : 0400005
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Linz, Austria, 4020
- Investigational Site Number : 0400004
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Maria Enzersdorf, Austria, 2344
- Investigational Site Number : 0400002
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Vienna, Austria, 1220
- Investigational Site Number : 0400001
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Brussels, Belgium, 1200
- Investigational Site Number : 0560002
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Edegem, Belgium, 2650
- Investigational Site Number : 0560007
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Gent, Belgium, 9000
- Investigational Site Number : 0560010
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Jette, Belgium, 1090
- Investigational Site Number : 0560003
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Leige, Belgium, 4000
- Investigational Site Number : 0560001
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Leuven, Belgium, 3000
- Investigational Site Number : 0560008
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Namur, Belgium, 5000
- Investigational Site Number : 0560004
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Roeselare, Belgium, 8800
- Investigational Site Number : 0560006
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Bogota, Colombia, 11001
- Investigational Site Number : 1700008
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Bogota, Colombia, 110221
- Investigational Site Number : 1700012
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Medellín, Colombia, 050034
- Investigational Site Number : 1700011
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Hradec Kralove, Czechia, 50005
- Investigational Site Number : 2030008
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Olomouc, Czechia, 77900
- Investigational Site Number : 2030006
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Ostrava - Poruba, Czechia, 70852
- Investigational Site Number : 2030003
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Plzen, Czechia, 304 60
- Investigational Site Number : 2030004
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Praha 1, Czechia, 110 01
- Investigational Site Number : 2030005
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Praha 5, Czechia, 150 06
- Investigational Site Number : 2030002
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Usti nad Labem, Czechia, 40113
- Investigational Site Number : 2030001
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Kokkola, Finland, 67200
- Investigational Site Number : 2460002
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Antony, France, 92160
- Investigational Site Number : 2500011
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Auxerre, France, 89000
- Investigational Site Number : 2500004
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Bordeaux, France, 33000
- Investigational Site Number : 2500003
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Montpellier Cedex 5, France, 34295
- Investigational Site Number : 2500009
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Pierre Benite cedex, France, 69495
- Investigational Site Number : 2500006
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Rouen, France, 76000
- Investigational Site Number : 2500010
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Saint-Mandé Cedex, France, 94160
- Investigational Site Number : 2500005
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Toulouse Cedex 9, France, 31059
- Investigational Site Number : 2500002
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Valence, France, 26953
- Investigational Site Number : 2500001
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Athens, Greece, 16121
- Investigational Site Number : 3000002
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Thessaloniki, Greece, 54645
- Investigational Site Number : 3000003
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Thessaloniki, Greece, 56403
- Investigational Site Number : 3000001
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Afula, Israel, 18101
- Investigational Site Number : 3760006
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Haifa, Israel, 3109601
- Investigational Site Number : 3760001
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Haifa, Israel, 31048
- Investigational Site Number : 3760005
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Jerusalem, Israel, 91120
- Investigational Site Number : 3760002
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Ramat Gan, Israel, 5266202
- Investigational Site Number : 3760004
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Rehovot, Israel, 76100
- Investigational Site Number : 3760003
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Bari, Italy, 70124
- Investigational Site Number : 3800012
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Brescia, Italy, 25123
- Investigational Site Number : 3800007
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Cagliari, Italy, 09124
- Investigational Site Number : 3800013
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Genova, Italy, 16132
- Investigational Site Number : 3800008
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L'Aquila, Italy, 67100
- Investigational Site Number : 3800015
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Milano, Italy, 20122
- Investigational Site Number : 3800004
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Napoli, Italy, 80131
- Investigational Site Number : 3800001
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Palermo, Italy, 90127
- Investigational Site Number : 3800018
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Pisa, Italy, 56126
- Investigational Site Number : 3800010
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Roma, Italy, 00137
- Investigational Site Number : 3800005
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Torino, Italy, 10126
- Investigational Site Number : 3800016
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Ancona
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Torrette Di Ancona, Ancona, Italy, 60126
- Investigational Site Number : 3800009
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Latina
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Terracina, Latina, Italy, 04019
- Investigational Site Number : 3800017
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Roma
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Rome, Roma, Italy, 00133
- Investigational Site Number : 3800003
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Rome, Roma, Italy, 00161
- Investigational Site Number : 3800011
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Amagasaki-shi, Japan, 660-8550
- Investigational Site Number : 3920022
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Habikino-shi, Japan, 583-8588
- Investigational Site Number : 3920002
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Hamamatsu-shi, Japan, 430-0929
- Investigational Site Number : 3920014
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Kyoto-shi, Japan, 604-8845
- Investigational Site Number : 3920025
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Marugame-shi, Japan, 763-0074
- Investigational Site Number : 3920013
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Minokamo-shi, Japan, 505-8503
- Investigational Site Number : 3920012
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Nagoya-shi, Japan, 454-8509
- Investigational Site Number : 3920001
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Setagaya-ku, Japan, 156-0043
- Investigational Site Number : 3920010
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Yokohama-shi, Japan, 234-8503
- Investigational Site Number : 3920020
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Aichi
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Nagakute-shi, Aichi, Japan, 480-1195
- Investigational Site Number : 3920004
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Hokkaido
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Obihiro-shi, Hokkaido, Japan, 080-0013
- Investigational Site Number : 3920015
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Sapporo-shi, Hokkaido, Japan, 060-0807
- Investigational Site Number : 3920006
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Osaka
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Hirakata-shi, Osaka, Japan, 573-1191
- Investigational Site Number : 3920011
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Saitama
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Koshigaya-shi, Saitama, Japan, 343-8555
- Investigational Site Number : 3920008
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Tochigi
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Shimotsuga-gun, Tochigi, Japan, 321-0293
- Investigational Site Number : 3920005
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Tokyo
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Itabashi-ku, Tokyo, Japan, 173-8606
- Investigational Site Number : 3920003
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Sulaibikat, Kuwait, 90806
- Investigational Site Number : 4140001
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Jalisco
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Guadalajara, Jalisco, Mexico, 44130
- Investigational Site Number : 4840001
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Bergen op Zoom, Netherlands, 4624 VT
- Investigational Site Number : 5280002
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Bergen, Norway, N-5021
- Investigational Site Number : 5780002
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Bodø, Norway, 8005
- Investigational Site Number : 5780001
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Coimbra, Portugal, 3000-075
- Investigational Site Number : 6200003
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Lisboa, Portugal, 1169-050
- Investigational Site Number : 6200002
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Porto, Portugal, 4099-001
- Investigational Site Number : 6200004
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Vila Nova de Gaia, Portugal, 4434-502
- Investigational Site Number : 6200001
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Moscow, Russian Federation, 123182
- Investigational Site Number : 6430001
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Moscow, Russian Federation, 129110
- Investigational Site Number : 6430002
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Saint-Petersburg, Russian Federation, 191015
- Investigational Site Number : 6430004
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Dammam, Saudi Arabia, 31444
- Investigational Site Number : 6820013
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Jeddah, Saudi Arabia, 21423
- Investigational Site Number : 6820001
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Baracaldo, Spain, 48903
- Investigational Site Number : 7240017
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Barcelona, Spain, 08041
- Investigational Site Number : 7240009
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Barcelona, Spain
- Investigational Site Number : 7240014
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Granada, Spain, 18012
- Investigational Site Number : 7240021
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Madrid, Spain, 28034
- Investigational Site Number : 7240006
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Madrid, Spain, 28041
- Investigational Site Number : 7240001
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Madrid, Spain, 28006
- Investigational Site Number : 7240016
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Madrid, Spain, 28031
- Investigational Site Number : 7240007
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Madrid, Spain, 28040
- Investigational Site Number : 7240010
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Santiago de Compostela, Spain, 15706
- Investigational Site Number : 7240008
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Asturias
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Oviedo, Asturias, Spain, 33011
- Investigational Site Number : 7240002
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Santullano De Mieres, Asturias, Spain, 33611
- Investigational Site Number : 7240011
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Bizkaia
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Bilbao, Bizkaia, Spain, 48013
- Investigational Site Number : 7240019
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Las Palmas
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Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
- Investigational Site Number : 7240004
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Madrid
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Majadahonda, Madrid, Spain, 28222
- Investigational Site Number : 7240012
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Kaohsiung, Taiwan, 833401
- Investigational Site Number : 1580012
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Taichung, Taiwan, 40201
- Investigational Site Number : 1580011
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Taipei, Taiwan, 100
- Investigational Site Number : 1580014
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Taoyuan County, Taiwan, 333
- Investigational Site Number : 1580015
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Abu Dhabi, United Arab Emirates, 34761
- Investigational Site Number : 7840002
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
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Participants with AD
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
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Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Baseline Characteristics: Medical history
Time Frame: Baseline to Month 60
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Baseline to Month 60
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Baseline Characteristics: Socio-demographics
Time Frame: Baseline to Month 60
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Baseline to Month 60
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Baseline Characteristics: Disease characteristics
Time Frame: Baseline to Month 60
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Baseline to Month 60
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis
Time Frame: Baseline to Month 60
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Percentage of BSA affected by AD assessed for each major section of the body
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Baseline to Month 60
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Physician Assessment: Eczema Area and Severity Index (EASI)
Time Frame: Baseline to Month 60
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Measure used in clinical practice and clinical trials to assess the severity and extent of AD
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Baseline to Month 60
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Physician Assessment: Scoring of Atopic Dermatitis (SCORAD)
Time Frame: Baseline to Month 60
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Measure used in clinical practice and clinical trials to standardize the evaluation of the severity and extent of AD
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Baseline to Month 60
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Participant Assessment: Patient Oriented Eczema Measure (POEM)
Time Frame: Baseline to Month 60
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Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults
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Baseline to Month 60
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Participant Assessment: Pruritus Numerical Rating Scale (NRS)
Time Frame: Baseline to Month 60
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Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale
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Baseline to Month 60
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Participant Assessment: Skin Pain or Soreness NRS
Time Frame: Baseline to Month 60
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Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS
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Baseline to Month 60
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Participant Assessment: Skin Feeling Hot NRS
Time Frame: Baseline to Month 60
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Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS
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Baseline to Month 60
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Participant Assessment: Skin Sensitivity NRS
Time Frame: Baseline to Month 60
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Individual NRS used to rate skin sensitivity using a 0 to 10 NRS
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Baseline to Month 60
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Participant Assessment: Sleep Disturbance NRS
Time Frame: Baseline to Month 60
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Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS
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Baseline to Month 60
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Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents
Time Frame: Baseline to Month 60
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Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL)
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Baseline to Month 60
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Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5)
Time Frame: Baseline to Month 60
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Questionnaire to evaluate asthma control in participants with comorbid asthma
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Baseline to Month 60
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Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS)
Time Frame: Baseline to Month 60
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Instrument for the documentation of symptoms and therapy monitoring in allergic rhinitis
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Baseline to Month 60
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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
Time Frame: Baseline to Month 60
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Questionnaire to assess the impact of AD on productivity
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Baseline to Month 60
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Participant Assessment: Health Care Resource Utilization Questionnaire
Time Frame: Baseline to Month 60
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Questionnaire regarding hospitalization, or emergency room/urgent care center visits due to AD
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Baseline to Month 60
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Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time Frame: Baseline to Month 60
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Instrument to measure treatment satisfaction
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Baseline to Month 60
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Adverse events (AEs)
Time Frame: Baseline to Month 60
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Number of participants with at least 1 AE
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Baseline to Month 60
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Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally
Time Frame: Baseline to Month 60
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Questionnaire related with Atopic dermatitis control
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Baseline to Month 60
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- OBS15990
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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