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

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT03559465

Collaborator

(none)

Enrollment

Location

Arms

49.1

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scleroderma, Systemic	Procedure: skin biopsy Other: Blood punction	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

Actual Study Start Date :

Oct 29, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fibroblast transcriptomic : myofibroblast signature [36 months]
expression of alpha Smooth Muscle Actin

Secondary Outcome Measures

Fibroblast transcriptomic [36 months]
expression of COL1A1, COL1A2, COL3A1 by quantitative RT-PCR
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Claude Huriez, CHU	Lille		France

Sponsors and Collaborators

University Hospital, Lille

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT03559465

Other Study ID Numbers:

2016_63
2017-A02720-53

First Posted:

Jun 18, 2018

Last Update Posted:

Oct 5, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Lille

systemic sclerosis

B lymphocyte

Additional relevant MeSH terms:

Scleroderma, Systemic

Scleroderma, Diffuse

Sclerosis

Study Results

No Results Posted as of Oct 5, 2021