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Completed

NCT Number: NCT03559465

Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

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.

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Key information

Conditions

Scleroderma, Systemic Connective Tissue Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Claude Huriez, CHU

Lille, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

skin biopsy

Procedure

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.

Blood punction

Other

1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of B lymphocyte

Primary outcomes

  1. Fibroblast transcriptomic : myofibroblast signature

    Time frame: 36 months

    expression of alpha Smooth Muscle Actin

Secondary outcomes

  1. Fibroblast transcriptomic

    Time frame: 36 months

    expression of COL1A1, COL1A2, COL3A1 by quantitative RT-PCR

  2. Difference in collagen infiltration by PicroSirius red staining between the skin biopsies of the two groups

    Time frame: 36 months

  3. Difference in the inflammatory infiltrate by immunohistological markings between the skin biopsies of the two groups

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: SCLERO-LB

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2018
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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