A Study in Male and Female Adult Patients With Atopic Dermatitis Treated With Dupilumab in Taiwan

Investigating Patterns of Phototherapy and Immunosuppressant Use in Adults with Atopic Dermatitis (a skin condition that causes itchy and inflamed skin)

Not Recruiting
18 years or above
All
Phase N/A
80 participants needed

Study Overview

Primary objective:

To characterize the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment for adult AD patients, who are eligible for dupilumab reimbursement in Taiwan (e.g., used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching).

Secondary objectives:

  • To characterize the adult AD patients, who are eligible for dupilumab reimbursement in Taiwan, with respect to their a) medical history, b) socio-demographic, c) disease characteristics, d) comorbid with type 2 diseases [e.g., Asthma, Chronic rhinosinusitis with nasal polyp (CRSwNP)], and e) prior and concomitant treatments of atopic dermatitis
  • To assess the effectiveness and safety of dupilumab in adult atopic dermatitis patients, who are eligible for dupilumab reimbursement in Taiwan
  • To assess comorbid atopic conditions and effects of dupilumab treatment for comorbid atopic conditions in adult patients, who are eligible for dupilumab reimbursement in Taiwan
  • To evaluate the correlation of patient reported outcome [Atopic Dermatitis Control Tool (ADCT)] and physician assessment [Eczema Area and Severity Index (EASI)] from the recruited subjects

Study Details

1 year

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Atopic Dermatitis
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Male or female, 18 years or older at the baseline visit
  • Initiating treatment with dupilumab for AD, who are eligible for dupilumab reimbursement according to the country-specific prescribing information

Note: Patients, who are diagnosed with AD more than 6 months, Eczema Area and Severity Index (EASI) more than or equals to 20. body surface area (of AD involvement) (BSA) more than or equals to 30% and IGA=3-4, may be eligible if they have already initiated treatment with:

  1. Phototherapy (psoralen + ultraviolet light A (PUVA) or narrow-band ultraviolet B (nb-UVB) twice a week) more than 3 months, and,
  2. Two different immunosuppressants (methotrexate, azathioprine, or cyclosporine) more than 3 months respectively before their enrollment in the registry.
    • Provided signed informed consent

Exclusion Criteria:

  • 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 the schedule of visits and assessments
  • Patients currently participating in any interventional clinical trial which modifies patient care
  • Patients who have a contraindication to dupilumab according to the country-specific prescribing information

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

Updated on 18 Jul 2024. Study ID: NCT05442645

The purpose of this study is to investigate how adults with atopic dermatitis (AD) in Taiwan use phototherapy and immunosuppressants before starting treatment with an investigational medication. Atopic dermatitis is a skin condition that causes itchy and inflamed skin. This study aims to understand the treatment patterns, including why new treatments are started and how long they are used, in patients who are eligible for reimbursement of the investigational medication.

Participants in this study will undergo various procedures, including assessments of their medical history, disease characteristics, and other health conditions like asthma and chronic rhinosinusitis. The study will also evaluate the effectiveness and safety of the investigational medication and its impact on related health conditions. Researchers will use tools like the Atopic Dermatitis Control Tool (ADCT) and the Eczema Area and Severity Index (EASI) to measure outcomes.

  • Who can participate: Adults aged 18 and older who are starting treatment with an investigational medication for atopic dermatitis and meet specific medical criteria may participate. Participants should have previously used phototherapy and two different immunosuppressants for more than three months each.
  • Study details: Participants will be assessed for their medical and treatment history, including the use of phototherapy and immunosuppressants. The study will involve evaluating the effectiveness and safety of an investigational medication for atopic dermatitis. Participants will report outcomes through tools like the Atopic Dermatitis Control Tool (ADCT) and the Eczema Area and Severity Index (EASI).
  • Study Timelines: The study will last 1 year.