Anti-nucleosome B Lymphocytes in Lupus (NCT01889654)

Study 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.

Conditions studied

Systemic Lupus Erythematosus With or Without Clinical Activity

In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 994 studies on the registry; 353 are open to participants now.

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Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

lupus patient and healthy volunteers

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Inclusion criteria

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

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 design

Observational model: Other
Time perspective: Prospective
Enrollment: 4 participants (actual)
Patient registry: No

Groups and cohorts

patient
Other: Venous blood sampling
healthy volunteers
Other: Venous blood sampling

Interventions

OtherVenous blood sampling

What researchers measure

Primary outcomes

all cause mortality
Time frame: 1 year

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01889654
Lead sponsor: University Hospital, Strasbourg, France
Responsible party: Sponsor
First posted: Jun 28, 2013
Start date: Feb 2014
Primary completion: Jul 2015
Completion: Jul 2015
Last update: Sep 11, 2017

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Anti-nucleosome B Lymphocytes in Lupus