Catalytic Antibodies and Lupus in Martinique (LUMAB2)
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|ClinicalTrials.gov Identifier: NCT01157468|
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : September 8, 2016
- The Martinique island (French West-Indies) is an area of high prevalence and incidence for Systemic Lupus Erythematosus (SLE), respectively 64,2/ 100000 and 4,7/ 100000. In many cases, this disease concerns Afro Caribbean women, whose auto-antibodies are excessively high; also, organic damages are frequent. The disease can be fatal.
- Studies have shown that some cytotoxic auto-antibodies may have a responsibility in the hydrolysing of DNA. This study will focus on the DNA activity and also on the overwhelm hydrolase activity dealing with the Lupus disease in order to measure the link between the disease activity and the catalytic activity. Patients concerned by this study will be Martinique people.
|Condition or disease|
|Systemic Lupus Erythematosus|
This study will be conducted as an case-control survey.
- The first group with patients: 60 SLE patients, 30 patients with a quiescent lupus and 30 patients with an active lupus. Patients that will be included are followed by the University hospital of Fort-de-France.
- The second group is the control group: subjects will be recruited by the French organisation responsible for donation of blood.
Test will be done at the UMRS 872 laboratory of the INSERM - Laboratory of Immunopathology and Therapeutic immunointervention - in Paris ; two catalytic activities will be tested: the DNase activity and the hydrolase activity.
Means to analyse the two activities: digestion of plasmid and Affinity-linked Oligonucleotide Nuclease Assay for DNase activity and hydrolysis of a peptide PFR-MCA for hydrolase activity.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Observational Model:||Case Control|
|Official Title:||Study of Catalytic Antibodies in a Cohort Population of Martinique|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
The "Case" group is constituted with patients with Systemic Lupus Erythematosus from Martinique, divided en 2:
The "Control" group is constituted by people coming to give blood to the French Blood Establishment of Martinique.
- Frequency of hydrolase and DNase activities [ Time Frame: 2 years ]Estimate the presence of a significant enzymatic activity by calculating the frequency of the hydrolase and DNase activities in lupus in Martinique(French west-indies)
- Association of disease activity and catalytic activity [ Time Frame: 2 years ]Evaluate the strength of the association of disease activity and catalytic activity of antibodies (quiescent / active and control / patient)
Biospecimen Retention: Samples With DNA
- For the "case" means the research will be done on a blood sample of 7 ml, reclassified from treatement to research, collected from the blood sampling usually prescribed by doctors to treat the patient come to be diagnosed a lupus or for continuing care.
- For the "control" means research will be done on a blood sample of 7 ml collected from people coming to donate blood at thethe French Blood Establishment of Martinique.
The volume does not exceed the maximum amount allowed by French regulations for blood donation.
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): NCT01157468
|Centre Hospitalier Universitaire de Fort de France|
|Fort de France, Martinique, France, 97261|
|Principal Investigator:||Christophe DELIGNY, MD||Service de Médecine Interne - Centre Hospitalier Universiatire de Fort de France|