Catalytic Antibodies and Lupus in Martinique

Completed

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT01157468
• Lead Sponsor: University Hospital Center of Martinique

Brief Summary

* 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-07-05
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-07
• Study Start: 2012-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of hydrolase and DNase activities	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)

Secondary Outcome Measures

Name	Time	Method
Association of disease activity and catalytic activity	2 years	Evaluate the strength of the association of disease activity and catalytic activity of antibodies (quiescent / active and control / patient)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Fort de France; 🇫🇷 Fort de France, Martinique, France

Centre Hospitalier Universitaire de Fort de France

🇫🇷Fort de France, Martinique, France