Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis. (SCLERO-LB)

University Hospital, Lille

Status: Completed

Conditions: Scleroderma, Systemic

Treatments: Other: Blood punction; Procedure: skin biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03559465

2017-A02720-53 (Other Identifier)

2016_63

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

patient with Scs

Experimental group

Description:

patients with SSc, (10 diffuse forms and 20 limited forms)

Treatment:

Procedure: skin biopsy

Other: Blood punction

healthy subject

Sham Comparator group

Treatment:

Other: Blood punction