Clinical trial

French Prospective Observational Study of Patients Receiving Dupilumab for Atopic Dermatitis.

Name

OBS17668

Description

This is a long-term study to collect data over 3 years in order to find out what is likely to happen in the future regarding participants 6 years of age and older who receive dupilumab for Atopic Dermatitis (AD) commonly known as Eczema, and to characterize real-world effectiveness, safety and use patterns of dupilumab in real world setting in France. Patients will be invited to participate if initiating treatment with dupilumab for AD according to French-specific prescribing information. The decision of initiation of the treatment is independent to the study's participation. The study will be conducted in approximately 50 centers in France to evaluate a representative sample of patients treated in France. At each participating site, all AD participants who receive an initial prescription for dupilumab will be invited to participate in this study, until the enrollment goal is achieved.

Trial arms

Trial start

2023-11-28

Estimated PCD

2027-11-29

Trial end

2027-11-29

Status

Recruiting

Treatment

Dupilumab

Dupilumab cohort

Arms:

Participants with AD treated with dupilumab

Other names:

SAR231893, Dupixent®

Size

500

Primary endpoint

Demographic characteristics of participants who receive dupilumab for AD

At baseline

Weight characteristics of participants who receive dupilumab for AD

At baseline

Height characteristics of participants who receive dupilumab for AD

At baseline

Medical history characteristics of participants who receive dupilumab for AD

At baseline

Comorbidities and treatments change from baseline

At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Atopic comorbidities and treatments change from baseline

At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in lifestyle habits of participants who receive dupilumab for AD

At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36 if applicable

Change from baseline in dupilumab dose

At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in dupilumab administration

At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in dupilumab compliance with treatment

At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in dupilumab temporary or permanent discontinuation

At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in dupilumab treatment switch to another therapy

At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in dupilumab treatment for concomitant AD treatments

At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change in patient's treatment satisfaction score using the Patient Global Assessment of Treatment Effect (PGATE)

At month 6, month 12, month 18, month 24, month 30, month 36

Change in eczema severity using the Eczema Area and Severity Index (EASI)

At baseline, month 6, month 12, month 18, month 24, month 30, month 36

Change in AD disease control using the Atopic Dermatitis Control Tool (ADCT)

At baseline, month 6, month 12, month 18, month 24, month 30, month 36

Change in Worst-Itch Numeric Rating Scale (WI-NRS)

At baseline, month 6, month 12, month 18, month 24, month 30, month 36

Change in sleep disturbance NRS

At baseline, month 6, month 12, month 18, month 24, month 30, month 36

Change in global patient's disease evaluation using the Patient Global Assessment of Disease Severity (PGADS)

At baseline, month 6, month 12, month 18, month 24, month 30, month 36

Change in global patient's disease evaluation using the Caregiver Global Assessment of Disease (CGAD)

At baseline, month 6, month 12, month 18, month 24, month 30, month 36

Change in Dermatology Life Quality Index (DLQI)

At baseline, month 6, month 12, month 18, month 24, month 30, month 36

Change in European Quality of Life-5 Dimensions-3 level score (EQ-5D-3L)

At baseline, month 6, month 12, month 18, month 24, month 30, month 36

Change in Work Productivity and Activity Impairment Questionnaire, Atopic Dermatitis (WPAI-AD)

At month 6, month 12, month 18, month 24, month 30, month 36

Number of Adverse Events (AE)

At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Change from baseline in Drug Survival

At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36

Eligibility criteria

Inclusion Criteria: * Male or female, 6 years or older. * Initiating treatment with dupilumab for AD according to French-specific prescribing information (≥ 12 years old: moderate to severe AD versus 6-11 years old: severe AD). The decision of initiation of the treatment is independent to the study's participation. * Able to understand and complete study-related questionnaires. * Signed informed consent form. For participants \<18 years old, Informed consent form signed by the parent/legal guardian and participant's assent obtained. Exclusion Criteria: * Patients who have a contraindication to the drug according to the French-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 comorbidities that can predictably prevent the patient from adequately completing, as per routine care, the schedule of visits and assessments. * Patients currently participating in any interventional clinical trial. * Patients previously treated with dupilumab. * Patients under tutorship or curatorship; patients under safeguard of justice or deprived of his/her liberty by an administrative or court decision.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}

Updated at

2023-12-14

1 organization

1 product

1 indication

Product

Dupilumab

Indication

Atopic Dermatitis

Organization

Sanofi