NCT03559465CompletedNot Applicable
Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.
University Hospital, Lille1 site in 1 country71 target enrollmentStarted: October 29, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Fibroblast transcriptomic : myofibroblast signature
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •systemic sclerosis according to ACR-EULAR 2013
- •written consent
- •available insurance
- •Healthy "blood" and healthy "biopsy" controls
- •written consent
- •available insurance
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Fibroblast transcriptomic : myofibroblast signature
Time Frame: 36 months
expression of alpha Smooth Muscle Actin
Secondary Outcomes
- Fibroblast transcriptomic(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)
Investigators
Study Sites (1)
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