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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1269-6392 | Registry Identifier | ICTRP |
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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:
1 year
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with AD | Male or female, 18 years or older at the baseline visit initiated treatment with dupilumab for AD, who are eligible for dupilumab reimbursement according to the country-specific prescribing information |
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| Measure | Description | Time Frame |
|---|---|---|
| Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Used regimens | At baseline (Day 1) | |
| Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reason for initiation of new treatments | At baseline (Day 1) | |
| Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Concomitant therapies | At baseline (Day 1) | |
| Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Treatment durations | At baseline (Day 1) | |
| Characterization of the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment: Reasons for discontinuation and/or switching | At baseline (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of the patients who receive dupilumab for AD: Medical history | At baseline (Day 1) | |
| Characterization of the patients who receive dupilumab for AD: Socio-demographic data | At baseline (Day 1) |
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Inclusion Criteria:
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.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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AD patients, who are eligible for dupilumab reimbursement in Taiwan
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site-National Taiwan University Hospital | Taipei | Taiwan | China |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Characterization of the patients who receive dupilumab for AD: Prior and concomitant treatments of AD; percentage who were on dupilumab at the baseline/enrollment visit (Visit 1) | At baseline (Day 1) |
| Characterization of the patients who receive dupilumab for AD: Reason for initiation of dupilumab | At baseline (Day 1) |
| Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (Asthma Control Questionnaire (ACQ-5)) | At baseline (Day 1) |
| Characterization of the patients who receive dupilumab for AD: Baseline assessments of comorbid conditions (22-item Sino-Nasal Outcome Test (SNOT-22)) | At baseline (Day 1) |
| Characterization of real-world use patterns of dupilumab for AD: Dupilumab dose regimens used over the study, and the duration with each regimen | Up to 12 months |
| Characterization of real-world use patterns of dupilumab for AD: Percentage of patients whose dose (either the frequency of the strength) increased from starting regimen and reasons; percentage whose dose decreased from the starting regimen and reasons | Up to 12 months |
| Characterization of real-world use patterns of dupilumab for AD: Percent discontinuing dupilumab, including temporary or permanent discontinuation; reasons for discontinuation | Up to 12 months |
| Characterization of real-world use patterns of dupilumab for AD: Longest duration of use | Up to 12 months |
| Characterization of real-world use patterns of dupilumab for AD: Number of gaps in dupilumab treatment and longest gap length | Up to 12 months |
| Characterization of real-world use patterns of dupilumab for AD: Concomitant therapies taken for AD | Up to 12 months |
| Effectiveness of dupilumab: change from baseline in Eczema Area and Severity Index (EASI) | Day 0, Months 3, 6, 9 and 12 |
| Effectiveness of dupilumab: change from baseline in body surface area (of AD involvement) (BSA) | Day 0, Months 3, 6, 9 and 12 |
| Effectiveness of dupilumab: change from baseline in Investigator global assessment scale (IGA) | Day 0, Months 3, 6, 9 and 12 |
| Effectiveness of dupilumab: change from baseline in Scoring of Atopic Dermatitis (SCORAD) | Day 0, Months 3, 6, 9 and 12 |
| Effectiveness of dupilumab: change from baseline in Patient-Oriented Eczema Measure (POEM) | Day 0, Months 3, 6, 9 and 12 |
| Effectiveness of dupilumab: change from baseline in Atopic Dermatitis Control Tools (ADCT) | Day 0, Months 3, 6, 9 and 12 |
| Effectiveness of dupilumab: change from baseline in Pruritus Numerical Rating Scale (NRS) | Day 0, Months 3, 6, 9 and 12 |
| Effectiveness of dupilumab: change from baseline in Sleep NRS | Day 0, Months 3, 6, 9 and 12 |
| Effectiveness of dupilumab: change from baseline in Dermatology Life Quality Index (DLQI) | Day 0, Months 3, 6, 9 and 12 |
| Effectiveness of dupilumab in relevant comorbid conditions: change in Juniper Asthma Control Questionnaire (ACQ-5) from the first reported time point of Asthma | Day 0 to Month 12 |
| Effectiveness of dupilumab in relevant comorbid conditions: change in 22-item Sino-Nasal Outcome Test (SNOT-22) from the first reported time point of Asthma | Day 0 to Month 12 |
| Percentage of participants reporting that their comorbid condition got better, and the percentage reporting their condition got worse at each follow-up visit by each specific condition (other than asthma and allergic rhinitis) | Day 0 to Month 12 |
| Safety: Number of patients with at least 1 adverse event (AE) | Day 0 to Month 12 |
| Safety: Annualized event rates of AEs | Day 0 to Month 12 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |