Anti-nucleosome B Lymphocytes in Lupus

Systemic Lupus Erythematosus With or Without Clinical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01889654
• Other study ID #: 5543
• Status: Terminated
• Phase: N/A
• First received: June 25, 2013
• Last updated: September 7, 2017
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus With or Without Clinical Activity

Intervention

Other:
• Venous blood sampling

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg	Bas Rhin

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		1 year