Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

Study Overview
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Brief Summary
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B Lymphocytes are thought to play an important role in the pathophysiology of systemic sclerosis. In this study, the profibrosing role of B lymphocytes of patients with systemic sclerosis will be evaluated.

Detailed Description
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B Lymphocytes of patients with systemic sclerosis will be assessed in term of interaction with fibroblasts from patients with systemic sclerosis and compared to healthy controls.

Official Title
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Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

Conditions
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Scleroderma, Systemic

Intervention / Treatment
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* Procedure: skin biopsy
* Other: Blood punction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients systemic sclerosis according to ACR-EULAR 2013 written consent available insurance Healthy blood and healthy biopsy controls written consent available insurance Exclusion Criteria: patients overlap with other connective tissue diseases immunosuppressants in the past 12 months corticosteroids ≥10mg/d pregnancy or breast feeding Healthy blood and healthy biopsy controls systemic sclerosis according to ACR-EULAR 2013 another connective tissue diseases immunosuppressants in the past 12 months corticosteroids ≥10mg/d pregnancy or breast feeding With dysimmune inflammatory diseases (except thyroiditis) Presenting an infection in progress or within the previous 15 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient with Scs<br>patients with SSc, (10 diffuse forms and 20 limited forms) | Procedure: skin biopsy<br>* A skin biopsy will be performed in 10 patients in the form of 2 punches of 5 mm in the injured area in aseptic condition with a Rodnan score. In this study, 10 skin biopsies are needed, and will be performed on the first 10 patients accepting this biopsy.<br>Other: Blood punction<br>* 1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of B lymphocyte<br>|
| Sham Comparator: healthy subject<br> | Other: Blood punction<br>* 1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of B lymphocyte<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibroblast transcriptomic : myofibroblast signature | expression of alpha Smooth Muscle Actin | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibroblast transcriptomic | expression of COL1A1, COL1A2, COL3A1 by quantitative RT-PCR | 36 months | 
| Difference in collagen infiltration by PicroSirius red staining between the skin biopsies of the two groups |  | 36 months | 
| Difference in the inflammatory infiltrate by immunohistological markings between the skin biopsies of the two groups |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic sclerosis, B lymphocyte