CompletedNot Applicable

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

Czechia146 participantsStarted 2022-12-30

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Trial details

NCT IDNCT05527964

SponsorSanofi

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-06-16

View on ClinicalTrials.gov More Atopic Dermatitis trials