Dermatitis, Atopic Clinical Trial
— JAKIGREATOfficial title:
Effectiveness and Safety of JAK Inhibitors for the Treatment of Moderate-to-severe Atopic Dermatitis in a Real-life French Multicenter Adult Cohort
Verified date | May 2021 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort
Status | Enrolling by invitation |
Enrollment | 150 |
Est. completion date | September 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults - moderate to severe atopic dermatitis - treated by JAK inhibitors between december 2020 and september 2021 - inefficiency, loss of efficiency or contra-indication of previous systemic agent, DUPILUMAB or phototherapy - ineligibility to French ongoing clinical trials Exclusion Criteria: - Children - mild atopic dermatitis - eligibility to CICLOSPORINE, METHOTREXATE, DUPILUMAB, phototherapy - eligibility to French ongoing clinical trials - patients' opposition for the use of their records - follow up <3 months |
Country | Name | City | State |
---|---|---|---|
France | Hop Claude Huriez Chu Lille | Lisle-sur-Tarn |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | reduction in Eczema Area and Severity Index (EASI) | At 3 months | ||
Secondary | SCORing Atopic Dermatitis (SCORAD) | at baseline and at 3 months | ||
Secondary | Investigator's Global Assessment (IGA) | at baseline and at 3 months | ||
Secondary | Dermatology Life Quality Index (DLQI) | at baseline and at 3 months | ||
Secondary | patient-reported pruritus score from 0 to 10 | at baseline and at 3 months | ||
Secondary | patient-reported sleep loss from 0 to 10 | at baseline and at 3 months | ||
Secondary | Adverse effects (biological and clinical) | at baseline and at 3 month |
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