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Trial record 24 of 378 for:    "Systemic Scleroderma"

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

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ClinicalTrials.gov Identifier: NCT03559465
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 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 : October 29, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

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




Primary Outcome Measures :
  1. Fibroblast transcriptomic : myofibroblast signature [ Time Frame: 36 months ]
    expression of alpha Smooth Muscle Actin


Secondary Outcome Measures :
  1. Fibroblast transcriptomic [ Time Frame: 36 months ]
    expression of COL1A1, COL1A2, COL3A1 by quantitative RT-PCR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

patients

  • systemic sclerosis according to ACR-EULAR 2013
  • written consent
  • available insurance

healthy 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559465


Contacts
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Contact: David Launay, MD,PhD 3 20 44 42 95 ext +33 david.launay@chru-lille.fr

Locations
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France
Hôpital Claude Huriez, CHU Recruiting
Lille, France
Principal Investigator: David Launay, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: David Launay, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03559465     History of Changes
Other Study ID Numbers: 2016_63
2017-A02720-53 ( Other Identifier: ID-RCB number, ANSM )
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
systemic sclerosis
B lymphocyte

Additional relevant MeSH terms:
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Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases