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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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:
Participants enrolled in the study will be followed for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab SAR231893 (REGN668) | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Characteristics: Medical history | Baseline to Month 60 | |
| Baseline Characteristics: Socio-demographics | Baseline to Month 60 | |
| Baseline Characteristics: Disease characteristics | Baseline to Month 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis | Percentage of BSA affected by AD assessed for each major section of the body | Baseline to Month 60 |
| Physician Assessment: Eczema Area and Severity Index (EASI) |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 0320013 | Pilar | Buenos Aires | B1629ODT | Argentina | ||
| Investigational Site Number : 0320012 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39621227 | Derived | Calzavara-Pinton P, Chu CY, Lapeere H, Rossi M, Ferrucci SM, Chung WH, Fougerousse AC, Fomina DS, Holzer G, Celakovska J, Al-Ahmad M, Tzellos T, Wu J, Ardeleanu M, Bosman K. One-Year Insights into the GLOBOSTAD Multinational Prospective Observational Study of Patients Receiving Dupilumab for Atopic Dermatitis. Adv Ther. 2025 Feb;42(2):720-733. doi: 10.1007/s12325-024-03049-8. Epub 2024 Dec 2. | |
| 37801232 |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Measure used in clinical practice and clinical trials to assess the severity and extent of AD
| Baseline to Month 60 |
| Physician Assessment: Scoring of Atopic Dermatitis (SCORAD) | Measure used in clinical practice and clinical trials to standardize the evaluation of the severity and extent of AD | Baseline to Month 60 |
| Participant Assessment: Patient Oriented Eczema Measure (POEM) | Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults | Baseline to Month 60 |
| Participant Assessment: Pruritus Numerical Rating Scale (NRS) | Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale | Baseline to Month 60 |
| Participant Assessment: Skin Pain or Soreness NRS | Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS | Baseline to Month 60 |
| Participant Assessment: Skin Feeling Hot NRS | Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS | Baseline to Month 60 |
| Participant Assessment: Skin Sensitivity NRS | Individual NRS used to rate skin sensitivity using a 0 to 10 NRS | Baseline to Month 60 |
| Participant Assessment: Sleep Disturbance NRS | Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS | Baseline to Month 60 |
| Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents | Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) | Baseline to Month 60 |
| Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5) | Questionnaire to evaluate asthma control in participants with comorbid asthma | Baseline to Month 60 |
| Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS) | Instrument for the documentation of symptoms and therapy monitoring in allergic rhinitis | Baseline to Month 60 |
| 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 | Questionnaire to assess the impact of AD on productivity | Baseline to Month 60 |
| Participant Assessment: Health Care Resource Utilization Questionnaire | Questionnaire regarding hospitalization, or emergency room/urgent care center visits due to AD | Baseline to Month 60 |
| Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9) | Instrument to measure treatment satisfaction | Baseline to Month 60 |
| Adverse events (AEs) | Number of participants with at least 1 AE | Baseline to Month 60 |
| Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally | Questionnaire related with Atopic dermatitis control | Baseline to Month 60 |
| Rosario |
| Santa Fe Province |
| S2000DBS |
| Argentina |
| Investigational Site Number : 0320011 | Ciudad Autonoma Bs As | C1121ABE | Argentina |
| Investigational Site Number : 0360002 | Kogarah | New South Wales | 2217 | Australia |
| Investigational Site Number : 0360005 | Kogarah | New South Wales | 2217 | Australia |
| Investigational Site Number : 0360003 | Woolloongabba | Queensland | 4102 | Australia |
| Investigational Site Number : 0360004 | Bedford Park | South Australia | 5042 | Australia |
| Investigational Site Number : 0360001 | Carlton | Victoria | 3053 | Australia |
| Investigational Site Number : 0400005 | Graz | 8036 | Austria |
| Investigational Site Number : 0400004 | Linz | 4020 | Austria |
| Investigational Site Number : 0400002 | Maria Enzersdorf | 2344 | Austria |
| Investigational Site Number : 0400001 | Vienna | 1220 | Austria |
| Investigational Site Number : 0560002 | Brussels | 1200 | Belgium |
| Investigational Site Number : 0560007 | Edegem | 2650 | Belgium |
| Investigational Site Number : 0560010 | Ghent | 9000 | Belgium |
| Investigational Site Number : 0560003 | Jette | 1090 | Belgium |
| Investigational Site Number : 0560001 | Leige | 4000 | Belgium |
| Investigational Site Number : 0560008 | Leuven | 3000 | Belgium |
| Investigational Site Number : 0560004 | Namur | 5000 | Belgium |
| Investigational Site Number : 0560006 | Roeselare | 8800 | Belgium |
| Investigational Site Number : 1700008 | Bogotá | 11001 | Colombia |
| Investigational Site Number : 1700012 | Bogotá | 110221 | Colombia |
| Investigational Site Number : 1700011 | Medellín | 050034 | Colombia |
| Investigational Site Number : 2030008 | Hradec Králové | 50005 | Czechia |
| Investigational Site Number : 2030006 | Olomouc | 77900 | Czechia |
| Investigational Site Number : 2030003 | Ostrava - Poruba | 70852 | Czechia |
| Investigational Site Number : 2030004 | Pilsen | 304 60 | Czechia |
| Investigational Site Number : 2030005 | Prague | 110 01 | Czechia |
| Investigational Site Number : 2030002 | Prague | 150 06 | Czechia |
| Investigational Site Number : 2030001 | Ústí nad Labem | 40113 | Czechia |
| Investigational Site Number : 2460002 | Kokkola | 67200 | Finland |
| Investigational Site Number : 2500011 | Antony | 92160 | France |
| Investigational Site Number : 2500004 | Auxerre | 89000 | France |
| Investigational Site Number : 2500003 | Bordeaux | 33000 | France |
| Investigational Site Number : 2500009 | Montpellier | 34295 | France |
| Investigational Site Number : 2500006 | Pierre-Bénite | 69495 | France |
| Investigational Site Number : 2500010 | Rouen | 76000 | France |
| Investigational Site Number : 2500005 | Saint-Mandé Cedex | 94160 | France |
| Investigational Site Number : 2500002 | Toulouse | 31059 | France |
| Investigational Site Number : 2500001 | Valence | 26953 | France |
| Investigational Site Number : 3000002 | Athens | 16121 | Greece |
| Investigational Site Number : 3000003 | Thessaloniki | 54645 | Greece |
| Investigational Site Number : 3000001 | Thessaloniki | 56403 | Greece |
| Investigational Site Number : 3760006 | Afula | 18101 | Israel |
| Investigational Site Number : 3760005 | Haifa | 31048 | Israel |
| Investigational Site Number : 3760001 | Haifa | 3109601 | Israel |
| Investigational Site Number : 3760002 | Jerusalem | 91120 | Israel |
| Investigational Site Number : 3760004 | Ramat Gan | 5266202 | Israel |
| Investigational Site Number : 3760003 | Rehovot | 76100 | Israel |
| Investigational Site Number : 3800009 | Torrette Di Ancona | Ancona | 60126 | Italy |
| Investigational Site Number : 3800017 | Terracina | Latina | 04019 | Italy |
| Investigational Site Number : 3800003 | Rome | Roma | 00133 | Italy |
| Investigational Site Number : 3800011 | Rome | Roma | 00161 | Italy |
| Investigational Site Number : 3800012 | Bari | 70124 | Italy |
| Investigational Site Number : 3800007 | Brescia | 25123 | Italy |
| Investigational Site Number : 3800013 | Cagliari | 09124 | Italy |
| Investigational Site Number : 3800008 | Genova | 16132 | Italy |
| Investigational Site Number : 3800015 | L’Aquila | 67100 | Italy |
| Investigational Site Number : 3800004 | Milan | 20122 | Italy |
| Investigational Site Number : 3800001 | Naples | 80131 | Italy |
| Investigational Site Number : 3800018 | Palermo | 90127 | Italy |
| Investigational Site Number : 3800010 | Pisa | 56126 | Italy |
| Investigational Site Number : 3800005 | Roma | 00137 | Italy |
| Investigational Site Number : 3800016 | Torino | 10126 | Italy |
| Investigational Site Number : 3920004 | Nagakute-shi | Aichi-ken | 480-1195 | Japan |
| Investigational Site Number : 3920015 | Obihiro-shi | Hokkaido | 080-0013 | Japan |
| Investigational Site Number : 3920006 | Sapporo | Hokkaido | 060-0807 | Japan |
| Investigational Site Number : 3920011 | Hirakata-shi | Osaka | 573-1191 | Japan |
| Investigational Site Number : 3920008 | Koshigaya-shi | Saitama | 343-8555 | Japan |
| Investigational Site Number : 3920005 | Shimotsuga-gun | Tochigi | 321-0293 | Japan |
| Investigational Site Number : 3920003 | Itabashi-ku | Tokyo | 173-8606 | Japan |
| Investigational Site Number : 3920022 | Amagasaki-shi | 660-8550 | Japan |
| Investigational Site Number : 3920002 | Habikino-shi | 583-8588 | Japan |
| Investigational Site Number : 3920014 | Hamamatsu | 430-0929 | Japan |
| Investigational Site Number : 3920025 | Kyoto | 604-8845 | Japan |
| Investigational Site Number : 3920013 | Marugame-shi | 763-0074 | Japan |
| Investigational Site Number : 3920012 | Minokamo-shi | 505-8503 | Japan |
| Investigational Site Number : 3920001 | Nagoya | 454-8509 | Japan |
| Investigational Site Number : 3920010 | Setagaya-ku | 156-0043 | Japan |
| Investigational Site Number : 3920020 | Yokohama | 234-8503 | Japan |
| Investigational Site Number : 4140001 | Sulaibikat | 90806 | Kuwait |
| Investigational Site Number : 4840001 | Guadalajara | Jalisco | 44130 | Mexico |
| Investigational Site Number : 5280002 | Bergen op Zoom | 4624 VT | Netherlands |
| Investigational Site Number : 5780002 | Bergen | N-5021 | Norway |
| Investigational Site Number : 5780001 | Bodø | 8005 | Norway |
| Investigational Site Number : 6200003 | Coimbra | 3000-075 | Portugal |
| Investigational Site Number : 6200002 | Lisbon | 1169-050 | Portugal |
| Investigational Site Number : 6200004 | Porto | 4099-001 | Portugal |
| Investigational Site Number : 6200001 | Vila Nova de Gaia | 4434-502 | Portugal |
| Investigational Site Number : 6430001 | Moscow | 123182 | Russia |
| Investigational Site Number : 6430002 | Moscow | 129110 | Russia |
| Investigational Site Number : 6430004 | Saint Petersburg | 191015 | Russia |
| Investigational Site Number : 6820013 | Dammam | 31444 | Saudi Arabia |
| Investigational Site Number : 6820001 | Jeddah | 21423 | Saudi Arabia |
| Investigational Site Number : 7240019 | Bilbao | Bizkaia | 48013 | Spain |
| Investigational Site Number : 7240004 | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Investigational Site Number : 7240012 | Majadahonda | Madrid | 28222 | Spain |
| Investigational Site Number : 7240002 | Oviedo | Principality of Asturias | 33011 | Spain |
| Investigational Site Number : 7240011 | Santullano de Mieres | Principality of Asturias | 33611 | Spain |
| Investigational Site Number : 7240017 | Barakaldo | 48903 | Spain |
| Investigational Site Number : 7240009 | Barcelona | 08041 | Spain |
| Investigational Site Number : 7240014 | Barcelona | Spain |
| Investigational Site Number : 7240021 | Granada | 18012 | Spain |
| Investigational Site Number : 7240016 | Madrid | 28006 | Spain |
| Investigational Site Number : 7240007 | Madrid | 28031 | Spain |
| Investigational Site Number : 7240006 | Madrid | 28034 | Spain |
| Investigational Site Number : 7240010 | Madrid | 28040 | Spain |
| Investigational Site Number : 7240001 | Madrid | 28041 | Spain |
| Investigational Site Number : 7240008 | Santiago de Compostela | 15706 | Spain |
| Investigational Site Number : 1580012 | Kaohsiung City | 833401 | Taiwan |
| Investigational Site Number : 1580011 | Taichung | 40201 | Taiwan |
| Investigational Site Number : 1580014 | Taipei | 100 | Taiwan |
| Investigational Site Number : 1580015 | Taoyuan County | 333 | Taiwan |
| Investigational Site Number : 7840002 | Abu Dhabi | 34761 | United Arab Emirates |
| Derived |
| Calzavara-Pinton P, Celakovska J, Lapeere H, Holzer G, Al-Ahmad M, Chu CY, Ferrucci SM, Kataoka Y, Rossi M, Fomina DS, Chung WH, Tzellos T, Fougerousse AC, Wu J, Ardeleanu M, Ozturk ZE. Baseline Demographics, Comorbidities, Treatment Patterns and Burden of Atopic Dermatitis in Adults and Adolescents from the GLOBOSTAD Long-Term Observational Study. Adv Ther. 2023 Dec;40(12):5366-5382. doi: 10.1007/s12325-023-02644-5. Epub 2023 Oct 6. |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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