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Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

NCT ID: NCT03559465

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-29

Study Completion Date

2023-02-14

Brief Summary

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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

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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.

Conditions

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Scleroderma, Systemic

Keywords

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systemic sclerosis B lymphocyte

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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patient with Scs

patients with SSc, (10 diffuse forms and 20 limited forms)

Group Type EXPERIMENTAL

skin biopsy

Intervention Type 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

Intervention Type 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

healthy subject

Group Type SHAM_COMPARATOR

Blood punction

Intervention Type 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

Interventions

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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.

Intervention Type PROCEDURE

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Launay, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Claude Huriez, CHU

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2017-A02720-53

Identifier Type: OTHER

Identifier Source: secondary_id

2016_63

Identifier Type: -

Identifier Source: org_study_id