NCT05442645Completed
A Study in Male and Female Adult Patients With Atopic Dermatitis Treated With Dupilumab in Taiwan
Observational Study of Atopic Dermatitis Patients Treated With Dupilumab in Taiwan
Source: ClinicalTrials.gov · Last updated 18 Jul 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 80 (actual)
- First submitted
- 22 Jun 2022
- Start date
- 20 Jul 2022
- Primary completion date
- 27 Jun 2023
- Lead sponsor
- Sanofi
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05442645
What you commit to
- Study type: Observational
- Participants enrolled: 80
- From 20 Jul 2022 to the primary completion date, 27 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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:
- Phototherapy (psoralen + ultraviolet light A (PUVA) or narrow-band ultraviolet B (nb-UVB) twice a week) more than 3 months, and,
- Two different immunosuppressants (methotrexate, azathioprine, or cyclosporine) more than 3 months respectively before their enrollment in the registry.
- Provided signed informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigational site-National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.