Anti-nucleosome B Lymphocytes in Lupus

Analysis of Frequency and Phenotype of Anti-nucleosome B Lymphocyte in Systemic Lupus

Lupus disease is characterized by the production of pathogenic autoantibodies, which participate in end-organ damages. The phenotype of B cells producing the pathogenic autoantibodies in lupus patients is today unknown. Antinucleosome antibodies are characteristic of lupus disease.This project proposes to detect antinucleosome B cells in lupus patients and to analyse their phenotype and their frequency.

Study Overview

• Status: Terminated
• Conditions: Systemic Lupus Erythematosus With or Without Clinical Activity
• Intervention / Treatment: Other: Venous blood sampling

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• France
  • Bas Rhin
    • Strasbourg, Bas Rhin, France, 67091
      • Les Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

lupus patient and healthy volunteers

Description

Inclusion criteria for SLE patients:

SLE patient : diagnostic based on ACR criteria

• SLE patient producing seric anti-nucleosome antibodies (ELISA)
• SLEDAI-2K activity score : inferior to 5 for quiescent patients, superior to 8 since at least 2 months for active patients

Exclusion criteria for SLE patients:

-- Other autoimmune diseases than SLE- Induced lupus

• Treatment with corticosteroids >10mg/d (prednisone) for quiescent patients
• Treatment with corticosteroids >20mg/d (prednisone) for active patients
• Oral immunosuppressive treatment during the last 6 months (methotrexate, azathioprine, ciclosporine, mycophénolate mofétil) for all patients, treatment during the last year with cyclophosphamide or monoclonal antibodies (rituximab, belimumab) for pour quiescent patients
• Disease which can modify B and T lymphocyte functions: primary immune deficiencies, evolutive infections, chronic viral infection (VIH in particular), chemotherapy or neoplasm antecedent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy volunteers	Other: Venous blood sampling
patient	Other: Venous blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all cause mortality	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (Estimate): June 28, 2013

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 5543