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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

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Sanofi

Status

Completed

Conditions

Atopic Dermatitis

Study type

Observational

Funder types

Industry

Identifiers

NCT05527964
U1111-1279-3216 (Registry Identifier)
OBS17350

Details and patient eligibility

About

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

Full description

28 weeks

Enrollment

146 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

146 participants in 1 patient group

Patients with severe refractory atopic dermatitis
Description:
Patients eligible for Dupixent therapy of AD

Trial contacts and locations

1

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Central trial contact

Trial Transparency email recommended (Toll free for US & Canada)

Data sourced from clinicaltrials.gov

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