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Anti-nucleosome B Lymphocytes in Lupus

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01889654
Enrollment
4
Registered
2013-06-28
Start date
2014-02-28
Completion date
2015-07-31
Last updated
2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus With or Without Clinical Activity

Brief 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.

Interventions

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
all cause mortality1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026