Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.
SCLERO-LB
2 other identifiers
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2018
CompletedFirst Posted
Study publicly available on registry
June 18, 2018
CompletedStudy Start
First participant enrolled
October 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2023
CompletedDecember 23, 2025
September 1, 2025
4.3 years
June 5, 2018
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fibroblast transcriptomic : myofibroblast signature
expression of alpha Smooth Muscle Actin
36 months
Secondary Outcomes (3)
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
Study Arms (2)
patient with Scs
EXPERIMENTALpatients with SSc, (10 diffuse forms and 20 limited forms)
healthy subject
SHAM COMPARATORInterventions
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.
1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of B lymphocyte
Eligibility Criteria
You may qualify if:
- patients
- systemic sclerosis according to ACR-EULAR 2013
- written consent
- available insurance
- Healthy "blood" and healthy "biopsy" controls
- written consent
- available insurance
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Claude Huriez, CHU
Lille, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Launay, MD,PhD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2018
First Posted
June 18, 2018
Study Start
October 29, 2018
Primary Completion
February 14, 2023
Study Completion
February 14, 2023
Last Updated
December 23, 2025
Record last verified: 2025-09