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Anti-nucleosome B Lymphocytes in Lupus

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ClinicalTrials.gov Identifier: NCT01889654
Recruitment Status : Terminated (recrutment difficulty)
First Posted : June 28, 2013
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus With or Without Clinical Activity Other: Venous blood sampling

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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Analysis of Frequency and Phenotype of Anti-nucleosome B Lymphocyte in Systemic Lupus
Actual Study Start Date : February 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
lupus patient and healthy volunteers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889654


Locations
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France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas Rhin, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01889654    
Other Study ID Numbers: 5543
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases