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
Quality of Life Study in Adults with Severe Atopic Dermatitis
Study Overview
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
Study Details
28 weeks
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Atopic Dermatitis
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Age: 18 years or above
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Gender: All
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.
This study investigates the quality of life in adult patients with severe refractory atopic dermatitis. The purpose is to assess how the treatment with an investigational medication affects the patients' quality of life, as measured by specific scales like EQ-5D, and the treatment response, measured by EASI75, by week 24.
Participants will undergo several assessments to track changes in disease activity, quality of life for both the patient and their family, sleep quality, anxiety, and depression over 16 and 24 weeks. The study will also evaluate the safety and tolerability of the treatment.
- Who can participate: Adults aged 18 years and older eligible for Dupixent therapy for atopic dermatitis who can follow the study regimen and complete questionnaires may participate. Informed consent is required.
- Study details: Participants will attend follow-up visits and complete questionnaires to evaluate quality of life and treatment response. The study will monitor changes in disease activity, sleep quality, and anxiety and depression levels.
- Study timelines: The study will last 28 weeks.
