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

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

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

Recruiting
18 years and older
All
Phase 1

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 adult AD patients in a real-world setting
  • To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in adult 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.

Eligibility

Inclusion criteria:
  • 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
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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study details
    ATOPIC DERMATITIS
    eczema (atopic dermatitis)
    ATOPIC DERMATITIS
    dermatitis
    atopic
    dermatitis
    atopic
    eczema (atopic dermatitis)

NCT03992417

Sanofi

25 February 2021

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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