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NCT04761978 Clinical Trial

Efficacy and Tolerance of JAK Inhibitors in ATU for Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

— JAKIGREAT  

Official title:
Effectiveness and Safety of JAK Inhibitors for the Treatment of Moderate-to-severe Atopic Dermatitis in a Real-life French Multicenter Adult Cohort

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04761978
Other study ID # NI_2021_01
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 2022

Study information
Verified date May 2021
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Hop Claude Huriez Chu Lille Lisle-sur-Tarn

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome
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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