Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

Not Applicable

Recruiting

• Conditions: Scleroderma, Systemic
• Interventions: Procedure: skin biopsy; Other: Blood punction

• Registration Number: NCT03559465
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-18
• Study Start: 2018-10-29
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient with Scs	Blood punction	patients with SSc, (10 diffuse forms and 20 limited forms)
healthy subject	Blood punction	-
patient with Scs	skin biopsy	patients with SSc, (10 diffuse forms and 20 limited forms)

Primary Outcome Measures

Name	Time	Method
Fibroblast transcriptomic : myofibroblast signature	36 months	expression of alpha Smooth Muscle Actin

Secondary Outcome Measures

Name	Time	Method
Fibroblast transcriptomic	36 months	expression of COL1A1, COL1A2, COL3A1 by quantitative RT-PCR
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

Trial Locations

Locations (1)

Hôpital Claude Huriez, CHU; 🇫🇷 Lille, France