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

Sanofi

Status: Active, not recruiting

Conditions: Dermatitis Atopic

Treatments: Drug: Dupilumab SAR231893 (REGN668)

Study type: Observational

Funder types: Industry

Identifiers

NCT03992417

OBS15990

Details and patient eligibility

About

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

Full description

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

Enrollment: 955 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

955 participants in 1 patient group

Participants with AD

Description:

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:

Drug: Dupilumab SAR231893 (REGN668)