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

December 16, 2025 updated by: University Hospital, Lille
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Claude Huriez, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient with Scs
patients with SSc, (10 diffuse forms and 20 limited forms)
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
Sham Comparator: healthy subject
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibroblast transcriptomic : myofibroblast signature
Time Frame: 36 months
expression of alpha Smooth Muscle Actin
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibroblast transcriptomic
Time Frame: 36 months
expression of COL1A1, COL1A2, COL3A1 by quantitative RT-PCR
36 months
Difference in collagen infiltration by PicroSirius red staining between the skin biopsies of the two groups
Time Frame: 36 months
36 months
Difference in the inflammatory infiltrate by immunohistological markings between the skin biopsies of the two groups
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: David Launay, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2018

Primary Completion (Actual)

February 14, 2023

Study Completion (Actual)

February 14, 2023

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Estimated)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_63
  • 2017-A02720-53 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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