Catalytic Antibodies and Lupus in Martinique

* 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Fort de France

Fort de France, Martinique, 97261, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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)

Secondary outcomes

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)

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Registry information

Official study title

Study of Catalytic Antibodies in a Cohort Population of Martinique

Acronym: LUMAB2

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jul 7, 2010
Registry last updated: Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed