Catalytic Antibodies and Lupus in Martinique (LUMAB2)

University Hospital Center of Martinique

Status: Completed

Conditions: Systemic Lupus Erythematosus

Study type: Observational

Funder types: Other

Identifiers

NCT01157468

10/E/12

Details and patient eligibility

About

• 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.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For patients:

• Presence of systemic lupus erythematosus according to the criteria of the modified 1997 ARA 1982 Lupus systemic evolution: Rates of anti DNA> 100 U/L in ELISA and SLEDAI> 7. Quiescent systemic Lupus: SLEDAI <7
• Be aged 18 years and over
• Patient who has his main home in Martinique
• Patient who gave his agreement to participate in this clinical study

For control subjects:

• Voluntary donor who gave freely his agreement to participate in this study
• Be aged 18 years and over
• Patient who has his main home in Martinique
• Voluntary who gave his agreement to participate in this clinical study

Exclusion criteria

For patients:

• Presence of mixed connective tissue disease, Hashimoto
• Patients with other diseases: cancer, current infection
• Patient pregnant or breast-feeding
• Patient who refuse to participate in the study
• Patient not affiliated with a social security scheme (beneficiary or beneficiary)
• Specially Protected Persons (or under guardianship)
• Patient who has not his main home in Martinique

For control subjects:

• Voluntary donor who refused to participate in this study
• Voluntary who has not main home in Martinique

Trial design

200 participants in 2 patient groups

Cases

Description:

The "Case" group is constituted with patients with Systemic Lupus Erythematosus from Martinique, divided en 2: * 30 patients with a quiescent lupus * 30 patients with an active lupus

Controles

Description:

The "Control" group is constituted by people coming to give blood to the French Blood Establishment of Martinique.