Status:
TERMINATED
Anti-nucleosome B Lymphocytes in Lupus
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Systemic Lupus Erythematosus With or Without Clinical Activity
Eligibility:
All Genders
18-60 years
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 patient...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01889654
Start Date
February 1 2014
End Date
July 1 2015
Last Update
September 11 2017
Active Locations (1)
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1
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas Rhin, France, 67091