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Catalytic Antibodies and Lupus in Martinique

Study of Catalytic Antibodies in a Cohort Population of Martinique

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01157468
Acronym
LUMAB2
Enrollment
200
Registered
2010-07-07
Start date
2012-01-31
Completion date
2013-12-31
Last updated
2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus in Martinique, Hydrolase and DNase activities

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.

Interventions

None listed

Sponsors

University Hospital Center of Martinique
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of hydrolase and DNase activities2 yearsEstimate 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

MeasureTime frameDescription
Association of disease activity and catalytic activity2 yearsEvaluate the strength of the association of disease activity and catalytic activity of antibodies (quiescent / active and control / patient)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026