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Abnormalities of B Lymphocytes During Systemic Lupus

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ClinicalTrials.gov Identifier: NCT00401141
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : August 8, 2008
Sponsor:
Information provided by:
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date  ICMJE November 16, 2006
First Posted Date  ICMJE November 17, 2006
Last Update Posted Date August 8, 2008
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abnormalities of B Lymphocytes During Systemic Lupus
Official Title  ICMJE Phenotypic Characteristics and Transcriptomas of B Lymphocytes During Non Active Systemic Lupus Erythematosus
Brief Summary Previous experimental data strongly suggest that B lymphocytes have intrinsic abnormalities during lupus in mice spontaneously affected by the disease. This study tries to define these abnormalities by looking at the gene expression profile of purified B lymphocytes from patients with non active systemic lupus , compared with the gene expression profile of purified B lymphocytes from healthy donnors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Procedure: Blood samples
Study Arms  ICMJE Not Provided
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  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November¬†16,¬†2006)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion criteria:

  • non active systemic lupus

Exclusion criteria:

  • immunosuppressive drugs
  • more than 10 mg of prednisone per day
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00401141
Other Study ID Numbers  ICMJE 3156
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jean-Louis Pasquali, MD Hôpitaux Universitaires de Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP