Clinical trial NCT06169527: A Long-term Data Collection Study of Participants in France Aged 6 Years Old or More With Atopic Dermatitis Receiving Dupilumab
Official title: French Prospective Observational Study of Patients Receiving Dupilumab for Atopic Dermatitis.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2023-12-13
Enrollment: 302
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of interest for this study will be patients in France aged 6 years old or more with a diagnosis of AD either severe or moderate to severe (depending on age group) who initiate dupilumab in real world setting. The study will be conducted in real conditions of practice, dupilumab will be prescribed at the sole initiative of the participating physician irrespective of patient enrolment decision.

Brief summary: 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.


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.

Primary outcomes:
measure: Demographic characteristics of participants who receive dupilumab for AD
timeFrame: At baseline
measure: Weight characteristics of participants who receive dupilumab for AD
timeFrame: At baseline
measure: Height characteristics of participants who receive dupilumab for AD
timeFrame: At baseline
measure: Medical history characteristics of participants who receive dupilumab for AD
timeFrame: At baseline
measure: Comorbidities and treatments change from baseline
timeFrame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
measure: Atopic comorbidities and treatments change from baseline
timeFrame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change from baseline in lifestyle habits of participants who receive dupilumab for AD
timeFrame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36 if applicable
measure: Change from baseline in dupilumab dose
timeFrame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change from baseline in dupilumab administration
timeFrame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change from baseline in dupilumab compliance with treatment
timeFrame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change from baseline in dupilumab temporary or permanent discontinuation
timeFrame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change from baseline in dupilumab treatment switch to another therapy
timeFrame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change from baseline in dupilumab treatment for concomitant AD treatments
timeFrame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change in patient's treatment satisfaction score using the Patient Global Assessment of Treatment Effect (PGATE)
timeFrame: At month 6, month 12, month 18, month 24, month 30, month 36
measure: Change in eczema severity using the Eczema Area and Severity Index (EASI)
timeFrame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change in AD disease control using the Atopic Dermatitis Control Tool (ADCT)
timeFrame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change in itch assessment
timeFrame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change in sleep disturbance NRS
timeFrame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change in global patient's disease evaluation using the Patient Global Assessment of Disease Severity (PGADS)
timeFrame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change in global patient's disease evaluation using the Caregiver Global Assessment of Disease (CGAD)
timeFrame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change in Dermatitis Family Impact Questionnaire (DFI)
timeFrame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change in European Quality of Life-5 Dimensions-3 level score (EQ-5D-3L)
timeFrame: At baseline, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change in Work Productivity and Activity Impairment Questionnaire, Atopic Dermatitis (WPAI-AD)
timeFrame: At month 6, month 12, month 18, month 24, month 30, month 36
measure: Number of Adverse Events (AE)
timeFrame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
measure: Change from baseline in Drug Survival
timeFrame: At baseline, month 3, month 6, month 12, month 18, month 24, month 30, month 36
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Investigational Site Number: 2500041
city: Angers
country: France
facility: Investigational Site Number: 2500037
city: Argenteuil
country: France
facility: Investigational Site Number: 2500021
city: Armentières
country: France
facility: Investigational Site Number: 2500044
city: Arras
country: France
facility: Investigational Site Number: 2500018
city: Ars Laquenexy
country: France
facility: Investigational Site Number: 2500011
city: Avignon
country: France
facility: Investigational Site Number: 2500023
city: Besançon
country: France
facility: Investigational Site Number: 2500001
city: Bron
country: France
facility: Investigational Site Number: 2500003
city: Caen
country: France
facility: Investigational Site Number: 2500043
city: Chambery
country: France
facility: Investigational Site Number: 2500050
city: Clermont Ferrand
country: France
facility: Investigational Site Number: 2500006
city: Dijon
country: France
facility: Investigational Site Number: 2500005
city: Epagny Metz Tessy
country: France
facility: Investigational Site Number: 2500004
city: Fort-de-France
country: France
facility: Investigational Site Number: 2500039
city: La Tronche
country: France
facility: Investigational Site Number: 2500045
city: Le Mans
country: France
facility: Investigational Site Number: 2500040
city: Les Sables d'Olonne
country: France
facility: Investigational Site Number: 2500038
city: Levallois-Perret
country: France
facility: Investigational Site Number: 2500048
city: Lille
country: France
facility: Investigational Site Number: 2500032
city: Limoges
country: France
facility: Investigational Site Number: 2500002
city: Lorient
country: France
facility: Investigational Site Number: 2500036
city: Marseille
country: France
facility: Investigational Site Number: 2500029
city: Montivilliers
country: France
facility: Investigational Site Number: 2500019
city: Montpellier
country: France
facility: Investigational Site Number: 2500028
city: Nantes
country: France
facility: Investigational Site Number: 2500024
city: Nice
country: France
facility: Investigational Site Number: 2500020
city: Nice
country: France
facility: Investigational Site Number: 2500025
city: Pau
country: France
facility: Investigational Site Number: 2500016
city: Poitiers
country: France
facility: Investigational Site Number: 2500042
city: Pontoise
country: France
facility: Investigational Site Number: 2500022
city: Périgueux
country: France
facility: Investigational Site Number: 2500009
city: Romans sur Isère
country: France
facility: Investigational Site Number: 2500014
city: Rouen
country: France
facility: Investigational Site Number: 2500008
city: Saint Germain en Laye
country: France
facility: Investigational Site Number: 2500015
city: Saint Mandé
country: France
facility: Investigational Site Number: 2500027
city: Saint Nazaire
country: France
facility: Investigational Site Number: 2500026
city: Saint-Pierre
country: France
facility: Investigational Site Number: 2500035
city: Saint-Pierre
country: France
facility: Investigational Site Number: 2500013
city: Toulouse
country: France
facility: Investigational Site Number: 2500012
city: Valence
country: France
facility: Investigational Site Number: 2500010
city: Vandoeuvre-lès-Nancy
country: France
facility: Investigational Site Number: 2500031
Study officials:
References: