Clinical trial NCT05527964: A Study to Evaluate the Quality of Life of Male and Female Adult Patients With Severe Refractory Atopic Dermatitis Treated With Dupilumab in Czech Republic
Official title: The Influence of Specific Targeted Therapy on Subject and Family Quality of Life, Anxiety, Depression and Sleep Quality in Patients With Severe Refractory Atopic Dermatitis in the Czech Republic
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-09-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for Dupixent therapy of atopic dermatitis (AD) according to the current summary of product characteristics (SPC) and reimbursement criteria given by the State Institute for Drug Control (SUKL) in Czech Republic

Brief summary: Assessment of the relationship between treatment response (EASI75) and change in quality of life (EQ-5D) by week 24.

Description of the:

* Change in disease activity after 16 and 24 weeks
* Change in subject and family quality of life after 16 and 24 weeks
* Change in sleep quality after 16 and 24 weeks
* Change in anxiety after 16 and 24 weeks
* Change in depression after 16 and 24 weeks
* Safety and tolerability

Detailed description: 28 weeks

Eligibility criteria: Inclusion Criteria:

* Patient eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL
* Signed informed consent
* 18 years and older (study questionnaires are validated for this age group). Patient is able to follow the prescribed regimen, routine follow-up visits and to fill the questionnaires

Exclusion Criteria:

- Patient not eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Primary outcomes:
measure: The regression coefficient for at least 75% reduction in the Eczema Area and Severity Index score (EASI75) at week 24 adjusted to baseline characteristics predicting the change in EQ-5D utility
timeFrame: At Week 24
Secondary outcomes:
measure: Change in disease activity (Eczema Area and Severity Index (EASI) score)
timeFrame: At Week 16 and Week 24
measure: Change in subject generic quality of life (European Quality of Life Five Dimension questionnaire (EQ-5D) utility)
timeFrame: At Week 16 and Week 24
measure: Change in Dermatology Life Quality Index (DLQI score)
timeFrame: At Week 16 and Week 24
measure: Change in Family Dermatology Life Quality Index (FDLQI score)
timeFrame: At Week 16
measure: Change in sleep quality (Jenkins Sleep Evaluation Questionnaire (JSEQ) score)
timeFrame: At Week 16 and Week 24
measure: Change in anxiety (Clinically Useful Anxiety Outcome Scale (CUXOS) score)
timeFrame: At Week 16 and Week 24
measure: Change in depression (Clinically Useful Depression Outcome Scale (CUDOS) score)
timeFrame: At Week 16 and Week 24
measure: Total number of adverse events
timeFrame: At Week 16 and Week 24
measure: Number of serious adverse events (SAEs)
timeFrame: At Week 16 and Week 24
measure: Number of non-serious adverse events (non-SAEs)
timeFrame: At Week 16 and Week 24
measure: Total number of discontinuations
timeFrame: At Week 16 and Week 24
measure: Reasons for discontinuations
timeFrame: At Week 16 and Week 24
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Investigational Site: Bulovka University Hospital
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: