Language: BG BG
← Back to results
Active (not recruiting) NCT03992417

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

Conditions: Dermatitis Atopic

Sponsor: Sanofi

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 21
Argentina (1)
Investigational Site Number : 0320013
Pilar , Buenos Aires
Australia (1)
Investigational Site Number : 0360002
Kogarah , New South Wales
Belgium (1)
Investigational Site Number : 0560002
Brussels
Colombia (1)
Investigational Site Number : 1700008
Bogotá
Czech Republic (1)
Investigational Site Number : 2030008
Hradec Králové
Finland (1)
Investigational Site Number : 2460002
Kokkola
France (1)
Investigational Site Number : 2500011
Antony
Greece (1)
Investigational Site Number : 3000002
Athens
Israel (1)
Investigational Site Number : 3760006
Afula
Italy (1)
Investigational Site Number : 3800009
Torrette Di Ancona , Ancona
Japan (1)
Investigational Site Number : 3920004
Nagakute-shi , Aichi-ken
Kuwait (1)
Investigational Site Number : 4140001
Sulaibikat
Mexico (1)
Investigational Site Number : 4840001
Guadalajara , Jalisco
Netherlands (1)
Investigational Site Number : 5280002
Bergen op Zoom
Norway (1)
Investigational Site Number : 5780002
Bergen
Portugal (1)
Investigational Site Number : 6200003
Coimbra
Russia (1)
Investigational Site Number : 6430001
Moscow
Saudi Arabia (1)
Investigational Site Number : 6820013
Dammam
Spain (1)
Investigational Site Number : 7240019
Bilbao , Bizkaia
Taiwan (1)
Investigational Site Number : 1580012
Kaohsiung City
United Arab Emirates (1)
Investigational Site Number : 7840002
Abu Dhabi
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
11.06.2019
Completion date
31.03.2027
Registry ID
NCT03992417
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.