Status:
UNKNOWN
Phenotypic and Functional Characterisation of Human B-cell Response in Pemphigus
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Pemphigus Vulgaris
Pemphigus Foliaceus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pemphigus is a rare autoimmune disease involving skin and mucous membranes characterized by the production of pathogenic autoantibodies directed against desmosomal transmembrane glycoproteins belongin...
Detailed Description
Pemphigus is a rare autoimmune disease involving skin and mucous membranes with an incidence estimated as 0.7 to 7 new cases per million per year, responsible for non-negligible morbidity and mortalit...
Eligibility Criteria
Inclusion
- Patients man or woman
- Patients above 18 years old
- Patients fulfilling the diagnostic criteria for pemphigus (Lever et al, 1979), or for lupus (SLICC 2012), or for rheumatoid arthritis (ACR / EULAR 2009 criteria), or for Gougerot-Sjögren's syndrome (ACR criteria / EULAR 2016)
- Clinically active disease, defined by the presence of erosions or cutaneo-mucous bubbles for pemphigus, a SLEDAI score\> 0 for lupus, a DAS28\> 0 score for rheumatoid arthritis, and an EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score\> 0 for Gougerot-Sjögren's syndrome
- Patients consenting to participate in the study
- Patients benefiting from the national healthcare insurance
Exclusion
- Pregnant or lactating woman
- Patient already treated with biotherapy
- Patient already receiving treatment that may affect lymphocyte B populations: corticosteroid therapy\> 10 mg / d or other immunosuppressant.
- Patient whose weight and / or hemoglobin level does not allow an additional blood sample during the assessment already provided by the treatment (according to the values in Appendix 2 of the Decree of April 12, 2018, which lists the research mentioned in 2 ° of Article L. 1121-1 of the Public Health Code)
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
Key Trial Info
Start Date :
October 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04117529
Start Date
October 22 2019
End Date
July 1 2022
Last Update
January 8 2021
Active Locations (1)
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1
Pr Philippe MUSETTE - Hôpital AVICENNE
Bobigny, France, 93000