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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03992417




Registration number
NCT03992417
Ethics application status
Date submitted
18/06/2019
Date registered
20/06/2019

Titles & IDs
Public title
Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)
Scientific title
A Prospective Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis
Secondary ID [1] 0 0
OBS15990
Universal Trial Number (UTN)
Trial acronym
GLOBOSTAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis Atopic 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab SAR231893 (REGN668)

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


Treatment: Drugs: Dupilumab SAR231893 (REGN668)
Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Baseline Characteristics: Medical history
Timepoint [1] 0 0
Baseline to Month 60
Primary outcome [2] 0 0
Baseline Characteristics: Socio-demographics
Timepoint [2] 0 0
Baseline to Month 60
Primary outcome [3] 0 0
Baseline Characteristics: Disease characteristics
Timepoint [3] 0 0
Baseline to Month 60
Secondary outcome [1] 0 0
Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis
Timepoint [1] 0 0
Baseline to Month 60
Secondary outcome [2] 0 0
Physician Assessment: Eczema Area and Severity Index (EASI)
Timepoint [2] 0 0
Baseline to Month 60
Secondary outcome [3] 0 0
Physician Assessment: Scoring of Atopic Dermatitis (SCORAD)
Timepoint [3] 0 0
Baseline to Month 60
Secondary outcome [4] 0 0
Participant Assessment: Patient Oriented Eczema Measure (POEM)
Timepoint [4] 0 0
Baseline to Month 60
Secondary outcome [5] 0 0
Participant Assessment: Pruritus Numerical Rating Scale (NRS)
Timepoint [5] 0 0
Baseline to Month 60
Secondary outcome [6] 0 0
Participant Assessment: Skin Pain or Soreness NRS
Timepoint [6] 0 0
Baseline to Month 60
Secondary outcome [7] 0 0
Participant Assessment: Skin Feeling Hot NRS
Timepoint [7] 0 0
Baseline to Month 60
Secondary outcome [8] 0 0
Participant Assessment: Skin Sensitivity NRS
Timepoint [8] 0 0
Baseline to Month 60
Secondary outcome [9] 0 0
Participant Assessment: Sleep Disturbance NRS
Timepoint [9] 0 0
Baseline to Month 60
Secondary outcome [10] 0 0
Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents
Timepoint [10] 0 0
Baseline to Month 60
Secondary outcome [11] 0 0
Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5)
Timepoint [11] 0 0
Baseline to Month 60
Secondary outcome [12] 0 0
Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS)
Timepoint [12] 0 0
Baseline to Month 60
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Baseline to Month 60
Secondary outcome [14] 0 0
Participant Assessment: Health Care Resource Utilization Questionnaire
Timepoint [14] 0 0
Baseline to Month 60
Secondary outcome [15] 0 0
Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Timepoint [15] 0 0
Baseline to Month 60
Secondary outcome [16] 0 0
Adverse events (AEs)
Timepoint [16] 0 0
Baseline to Month 60
Secondary outcome [17] 0 0
Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally
Timepoint [17] 0 0
Baseline to Month 60

Eligibility
Key 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
Accrual to date
Final
955
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360002 - Kogarah
Recruitment hospital [2] 0 0
Investigational Site Number : 0360005 - Kogarah
Recruitment hospital [3] 0 0
Investigational Site Number : 0360003 - Woolloongabba
Recruitment hospital [4] 0 0
Investigational Site Number : 0360004 - Bedford Park
Recruitment hospital [5] 0 0
Investigational Site Number : 0360001 - Carlton
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Santa Fe
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad Autonoma Bs As
Country [4] 0 0
Austria
State/province [4] 0 0
Graz
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
Austria
State/province [6] 0 0
Maria Enzersdorf
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussels
Country [9] 0 0
Belgium
State/province [9] 0 0
Edegem
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Jette
Country [12] 0 0
Belgium
State/province [12] 0 0
Leige
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Belgium
State/province [14] 0 0
Namur
Country [15] 0 0
Belgium
State/province [15] 0 0
Roeselare
Country [16] 0 0
Colombia
State/province [16] 0 0
Bogota
Country [17] 0 0
Colombia
State/province [17] 0 0
Medellín
Country [18] 0 0
Czechia
State/province [18] 0 0
Hradec Kralove
Country [19] 0 0
Czechia
State/province [19] 0 0
Olomouc
Country [20] 0 0
Czechia
State/province [20] 0 0
Ostrava - Poruba
Country [21] 0 0
Czechia
State/province [21] 0 0
Plzen
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 1
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha 5
Country [24] 0 0
Czechia
State/province [24] 0 0
Usti nad Labem
Country [25] 0 0
Finland
State/province [25] 0 0
Kokkola
Country [26] 0 0
France
State/province [26] 0 0
Antony
Country [27] 0 0
France
State/province [27] 0 0
Auxerre
Country [28] 0 0
France
State/province [28] 0 0
Bordeaux
Country [29] 0 0
France
State/province [29] 0 0
Montpellier Cedex 5
Country [30] 0 0
France
State/province [30] 0 0
Pierre Benite cedex
Country [31] 0 0
France
State/province [31] 0 0
Rouen
Country [32] 0 0
France
State/province [32] 0 0
Saint-Mandé Cedex
Country [33] 0 0
France
State/province [33] 0 0
Toulouse Cedex 9
Country [34] 0 0
France
State/province [34] 0 0
Valence
Country [35] 0 0
Greece
State/province [35] 0 0
Athens
Country [36] 0 0
Greece
State/province [36] 0 0
Thessaloniki
Country [37] 0 0
Israel
State/province [37] 0 0
Afula
Country [38] 0 0
Israel
State/province [38] 0 0
Haifa
Country [39] 0 0
Israel
State/province [39] 0 0
Jerusalem
Country [40] 0 0
Israel
State/province [40] 0 0
Ramat Gan
Country [41] 0 0
Israel
State/province [41] 0 0
Rehovot
Country [42] 0 0
Italy
State/province [42] 0 0
Ancona
Country [43] 0 0
Italy
State/province [43] 0 0
Latina
Country [44] 0 0
Italy
State/province [44] 0 0
Roma
Country [45] 0 0
Italy
State/province [45] 0 0
Bari
Country [46] 0 0
Italy
State/province [46] 0 0
Brescia
Country [47] 0 0
Italy
State/province [47] 0 0
Cagliari
Country [48] 0 0
Italy
State/province [48] 0 0
Genova
Country [49] 0 0
Italy
State/province [49] 0 0
L'Aquila
Country [50] 0 0
Italy
State/province [50] 0 0
Milano
Country [51] 0 0
Italy
State/province [51] 0 0
Napoli
Country [52] 0 0
Italy
State/province [52] 0 0
Palermo
Country [53] 0 0
Italy
State/province [53] 0 0
Pisa
Country [54] 0 0
Italy
State/province [54] 0 0
Torino
Country [55] 0 0
Japan
State/province [55] 0 0
Aichi
Country [56] 0 0
Japan
State/province [56] 0 0
Hokkaido
Country [57] 0 0
Japan
State/province [57] 0 0
Osaka
Country [58] 0 0
Japan
State/province [58] 0 0
Saitama
Country [59] 0 0
Japan
State/province [59] 0 0
Tochigi
Country [60] 0 0
Japan
State/province [60] 0 0
Tokyo
Country [61] 0 0
Japan
State/province [61] 0 0
Amagasaki-shi
Country [62] 0 0
Japan
State/province [62] 0 0
Habikino-shi
Country [63] 0 0
Japan
State/province [63] 0 0
Hamamatsu-shi
Country [64] 0 0
Japan
State/province [64] 0 0
Kyoto-shi
Country [65] 0 0
Japan
State/province [65] 0 0
Marugame-shi
Country [66] 0 0
Japan
State/province [66] 0 0
Minokamo-shi
Country [67] 0 0
Japan
State/province [67] 0 0
Nagoya-shi
Country [68] 0 0
Japan
State/province [68] 0 0
Setagaya-ku
Country [69] 0 0
Japan
State/province [69] 0 0
Yokohama-shi
Country [70] 0 0
Kuwait
State/province [70] 0 0
Sulaibikat
Country [71] 0 0
Mexico
State/province [71] 0 0
Jalisco
Country [72] 0 0
Netherlands
State/province [72] 0 0
Bergen op Zoom
Country [73] 0 0
Norway
State/province [73] 0 0
Bergen
Country [74] 0 0
Norway
State/province [74] 0 0
Bodø
Country [75] 0 0
Portugal
State/province [75] 0 0
Coimbra
Country [76] 0 0
Portugal
State/province [76] 0 0
Lisboa
Country [77] 0 0
Portugal
State/province [77] 0 0
Porto
Country [78] 0 0
Portugal
State/province [78] 0 0
Vila Nova de Gaia
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Moscow
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Saint-Petersburg
Country [81] 0 0
Saudi Arabia
State/province [81] 0 0
Dammam
Country [82] 0 0
Saudi Arabia
State/province [82] 0 0
Jeddah
Country [83] 0 0
Spain
State/province [83] 0 0
Asturias
Country [84] 0 0
Spain
State/province [84] 0 0
Bizkaia
Country [85] 0 0
Spain
State/province [85] 0 0
Las Palmas
Country [86] 0 0
Spain
State/province [86] 0 0
Madrid
Country [87] 0 0
Spain
State/province [87] 0 0
Baracaldo
Country [88] 0 0
Spain
State/province [88] 0 0
Barcelona
Country [89] 0 0
Spain
State/province [89] 0 0
Granada
Country [90] 0 0
Spain
State/province [90] 0 0
Santiago de Compostela
Country [91] 0 0
Taiwan
State/province [91] 0 0
Kaohsiung
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taichung
Country [93] 0 0
Taiwan
State/province [93] 0 0
Taipei
Country [94] 0 0
Taiwan
State/province [94] 0 0
Taoyuan County
Country [95] 0 0
United Arab Emirates
State/province [95] 0 0
Al Ain

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03992417