Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)

Dermatitis Atopic Clinical Trial

— GLOBOSTAD  

Official title:

A Prospective Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03992417
• Other study ID #: OBS15990
• Status: Active, not recruiting
• Start date: June 11, 2019
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 955
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Atopic
• Dermatitis, Atopic

Intervention

Drug:
• Dupilumab SAR231893 (REGN668)
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320011	Ciudad Autonoma Bs As
Argentina	Investigational Site Number : 0320013	Pilar	Buenos Aires
Argentina	Investigational Site Number : 0320012	Rosario	Santa Fe
Australia	Investigational Site Number : 0360004	Bedford Park	South Australia
Australia	Investigational Site Number : 0360001	Carlton	Victoria
Australia	Investigational Site Number : 0360002	Kogarah	New South Wales
Australia	Investigational Site Number : 0360005	Kogarah	New South Wales
Australia	Investigational Site Number : 0360003	Woolloongabba	Queensland
Austria	Investigational Site Number : 0400005	Graz
Austria	Investigational Site Number : 0400004	Linz
Austria	Investigational Site Number : 0400002	Maria Enzersdorf
Austria	Investigational Site Number : 0400001	Vienna
Belgium	Investigational Site Number : 0560002	Brussels
Belgium	Investigational Site Number : 0560007	Edegem
Belgium	Investigational Site Number : 0560010	Gent
Belgium	Investigational Site Number : 0560003	Jette
Belgium	Investigational Site Number : 0560001	Leige
Belgium	Investigational Site Number : 0560008	Leuven
Belgium	Investigational Site Number : 0560004	Namur
Belgium	Investigational Site Number : 0560006	Roeselare
Colombia	Investigational Site Number : 1700008	Bogota
Colombia	Investigational Site Number : 1700012	Bogota
Colombia	Investigational Site Number : 1700011	Medellín
Czechia	Investigational Site Number : 2030008	Hradec Kralove
Czechia	Investigational Site Number : 2030006	Olomouc
Czechia	Investigational Site Number : 2030003	Ostrava - Poruba
Czechia	Investigational Site Number : 2030004	Plzen
Czechia	Investigational Site Number : 2030005	Praha 1
Czechia	Investigational Site Number : 2030002	Praha 5
Czechia	Investigational Site Number : 2030001	Usti nad Labem
Finland	Investigational Site Number : 2460002	Kokkola
France	Investigational Site Number : 2500011	Antony
France	Investigational Site Number : 2500004	Auxerre
France	Investigational Site Number : 2500003	Bordeaux
France	Investigational Site Number : 2500009	Montpellier Cedex 5
France	Investigational Site Number : 2500006	Pierre Benite cedex
France	Investigational Site Number : 2500010	Rouen
France	Investigational Site Number : 2500005	Saint-Mandé Cedex
France	Investigational Site Number : 2500002	Toulouse Cedex 9
France	Investigational Site Number : 2500001	Valence
Greece	Investigational Site Number : 3000002	Athens
Greece	Investigational Site Number : 3000001	Thessaloniki
Greece	Investigational Site Number : 3000003	Thessaloniki
Israel	Investigational Site Number : 3760006	Afula
Israel	Investigational Site Number : 3760001	Haifa
Israel	Investigational Site Number : 3760005	Haifa
Israel	Investigational Site Number : 3760002	Jerusalem
Israel	Investigational Site Number : 3760004	Ramat Gan
Israel	Investigational Site Number : 3760003	Rehovot
Italy	Investigational Site Number : 3800012	Bari
Italy	Investigational Site Number : 3800007	Brescia
Italy	Investigational Site Number : 3800013	Cagliari
Italy	Investigational Site Number : 3800008	Genova
Italy	Investigational Site Number : 3800015	L'Aquila
Italy	Investigational Site Number : 3800004	Milano
Italy	Investigational Site Number : 3800001	Napoli
Italy	Investigational Site Number : 3800018	Palermo
Italy	Investigational Site Number : 3800010	Pisa
Italy	Investigational Site Number : 3800005	Roma
Italy	Investigational Site Number : 3800003	Rome	Roma
Italy	Investigational Site Number : 3800011	Rome	Roma
Italy	Investigational Site Number : 3800017	Terracina	Latina
Italy	Investigational Site Number : 3800016	Torino
Italy	Investigational Site Number : 3800009	Torrette Di Ancona	Ancona
Japan	Investigational Site Number : 3920022	Amagasaki-shi
Japan	Investigational Site Number : 3920002	Habikino-shi
Japan	Investigational Site Number : 3920014	Hamamatsu-shi
Japan	Investigational Site Number : 3920011	Hirakata-shi	Osaka
Japan	Investigational Site Number : 3920003	Itabashi-ku	Tokyo
Japan	Investigational Site Number : 3920008	Koshigaya-shi	Saitama
Japan	Investigational Site Number : 3920025	Kyoto-shi
Japan	Investigational Site Number : 3920013	Marugame-shi
Japan	Investigational Site Number : 3920012	Minokamo-shi
Japan	Investigational Site Number : 3920004	Nagakute-shi	Aichi
Japan	Investigational Site Number : 3920001	Nagoya-shi
Japan	Investigational Site Number : 3920015	Obihiro-shi	Hokkaido
Japan	Investigational Site Number : 3920006	Sapporo-shi	Hokkaido
Japan	Investigational Site Number : 3920010	Setagaya-ku
Japan	Investigational Site Number : 3920005	Shimotsuga-gun	Tochigi
Japan	Investigational Site Number : 3920020	Yokohama-shi
Kuwait	Investigational Site Number : 4140001	Sulaibikat
Mexico	Investigational Site Number : 4840001	Guadalajara	Jalisco
Netherlands	Investigational Site Number : 5280002	Bergen op Zoom
Norway	Investigational Site Number : 5780002	Bergen
Norway	Investigational Site Number : 5780001	Bodø
Portugal	Investigational Site Number : 6200003	Coimbra
Portugal	Investigational Site Number : 6200002	Lisboa
Portugal	Investigational Site Number : 6200004	Porto
Portugal	Investigational Site Number : 6200001	Vila Nova de Gaia
Russian Federation	Investigational Site Number : 6430001	Moscow
Russian Federation	Investigational Site Number : 6430002	Moscow
Russian Federation	Investigational Site Number : 6430004	Saint-Petersburg
Saudi Arabia	Investigational Site Number : 6820013	Dammam
Saudi Arabia	Investigational Site Number : 6820001	Jeddah
Spain	Investigational Site Number : 7240017	Baracaldo
Spain	Investigational Site Number : 7240009	Barcelona
Spain	Investigational Site Number : 7240014	Barcelona
Spain	Investigational Site Number : 7240019	Bilbao	Bizkaia
Spain	Investigational Site Number : 7240021	Granada
Spain	Investigational Site Number : 7240004	Las Palmas de Gran Canaria	Las Palmas
Spain	Investigational Site Number : 7240001	Madrid
Spain	Investigational Site Number : 7240006	Madrid
Spain	Investigational Site Number : 7240007	Madrid
Spain	Investigational Site Number : 7240010	Madrid
Spain	Investigational Site Number : 7240016	Madrid
Spain	Investigational Site Number : 7240012	Majadahonda	Madrid
Spain	Investigational Site Number : 7240002	Oviedo	Asturias
Spain	Investigational Site Number : 7240008	Santiago de Compostela
Spain	Investigational Site Number : 7240011	Santullano De Mieres	Asturias
Taiwan	Investigational Site Number : 1580012	Kaohsiung
Taiwan	Investigational Site Number : 1580011	Taichung
Taiwan	Investigational Site Number : 1580014	Taipei
Taiwan	Investigational Site Number : 1580015	Taoyuan County
United Arab Emirates	Investigational Site Number : 7840002	Al Ain

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Colombia,  Czechia,  Finland,  France,  Greece,  Israel,  Italy,  Japan,  Kuwait,  Mexico,  Netherlands,  Norway,  Portugal,  Russian Federation,  Saudi Arabia,  Spain,  Taiwan,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Characteristics: Medical history		Baseline to Month 60
Primary	Baseline Characteristics: Socio-demographics		Baseline to Month 60
Primary	Baseline Characteristics: Disease characteristics		Baseline to Month 60
Secondary	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
Secondary	Physician Assessment: Eczema Area and Severity Index (EASI)	Measure used in clinical practice and clinical trials to assess the severity and extent of AD	Baseline to Month 60
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Participant Assessment: Skin Sensitivity NRS	Individual NRS used to rate skin sensitivity using a 0 to 10 NRS	Baseline to Month 60
Secondary	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
Secondary	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
Secondary	Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5)	Questionnaire to evaluate asthma control in participants with comorbid asthma	Baseline to Month 60
Secondary	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
Secondary	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
Secondary	Participant Assessment: Health Care Resource Utilization Questionnaire	Questionnaire regarding hospitalization, or emergency room/urgent care center visits due to AD	Baseline to Month 60
Secondary	Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9)	Instrument to measure treatment satisfaction	Baseline to Month 60
Secondary	Adverse events (AEs)	Number of participants with at least 1 AE	Baseline to Month 60
Secondary	Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally	Questionnaire related with Atopic dermatitis control	Baseline to Month 60