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Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03559465
Acronym
SCLERO-LB
Enrollment
71
Registered
2018-06-18
Start date
2018-10-29
Completion date
2023-02-14
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleroderma, Systemic

Keywords

systemic sclerosis, B lymphocyte

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.

Interventions

PROCEDUREskin 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.

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fibroblast transcriptomic : myofibroblast signature36 monthsexpression of alpha Smooth Muscle Actin

Secondary

MeasureTime frameDescription
Fibroblast transcriptomic36 monthsexpression of COL1A1, COL1A2, COL3A1 by quantitative RT-PCR
Difference in collagen infiltration by PicroSirius red staining between the skin biopsies of the two groups36 months
Difference in the inflammatory infiltrate by immunohistological markings between the skin biopsies of the two groups36 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026