Anti-nucleosome B Lymphocytes in Lupus

NCT ID: NCT01889654

Last Updated: 2017-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus With or Without Clinical Activity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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patient

Venous blood sampling

Intervention Type OTHER

healthy volunteers

Venous blood sampling

Intervention Type OTHER

Interventions

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Venous blood sampling

Intervention Type OTHER

Eligibility Criteria

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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

\-- 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Les Hôpitaux Universitaires de Strasbourg

Strasbourg, Bas Rhin, France

Site Status

Countries

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France

Other Identifiers

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5543

Identifier Type: -

Identifier Source: org_study_id

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