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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

Tracking Information
First Submitted Date June 25, 2013
First Posted Date June 28, 2013
Last Update Posted Date September 11, 2017
Actual Study Start Date February 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2013)
all cause mortality [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Anti-nucleosome B Lymphocytes in Lupus
Official Title Analysis of Frequency and Phenotype of Anti-nucleosome B Lymphocyte in Systemic Lupus
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population lupus patient and healthy volunteers
Condition Systemic Lupus Erythematosus With or Without Clinical Activity
Intervention Other: Venous blood sampling
Study Groups/Cohorts
  • patient
    Intervention: Other: Venous blood sampling
  • healthy volunteers
    Intervention: Other: Venous blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: September 7, 2017)
4
Original Estimated Enrollment
 (submitted: June 27, 2013)
90
Actual Study Completion Date July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01889654
Other Study ID Numbers 5543
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Strasbourg, France
Verification Date January 2017