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NCT03559465 Clinical Trial

Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

Scleroderma, Systemic Clinical Trial

— SCLERO-LB  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03559465
Other study ID # 2016_63
Secondary ID 2017-A02720-53
Status Recruiting
Phase N/A
First received
Last updated
Start date October 29, 2018
Est. completion date December 2023

Study information
Verified date January 2023
Source University Hospital, Lille
Contact David Launay, MD,PhD
Phone 3 20 44 42 95
Email david.launay@chru-lille.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 71
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• skin biopsy
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.
Other:
• Blood punction
1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of B lymphocyte

Locations
Country Name City State
France Hôpital Claude Huriez, CHU Lille

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fibroblast transcriptomic : myofibroblast signature expression of alpha Smooth Muscle Actin 36 months
Secondary Fibroblast transcriptomic expression of COL1A1, COL1A2, COL3A1 by quantitative RT-PCR 36 months
Secondary Difference in collagen infiltration by PicroSirius red staining between the skin biopsies of the two groups 36 months
Secondary Difference in the inflammatory infiltrate by immunohistological markings between the skin biopsies of the two groups 36 months
See also
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