Clinical trial NCT01157468: Catalytic Antibodies and Lupus in Martinique
Official title: Study of Catalytic Antibodies in a Cohort Population of Martinique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus in Martinique
Hydrolase and DNase activities
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases are patients with Systemic Lupus Erythematosus treated at the Centre Hospitalier of Fort de France (Martinique): patients with a quiescent lupus and patients with an active lupus.

Controles are people coming to donate blood samples at the French Blood Establishment 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of hydrolase and DNase activities
timeFrame: 2 years
Secondary outcomes:
measure: Association of disease activity and catalytic activity
timeFrame: 2 years
Other outcomes:
Locations:
city: Fort de France
country: France
facility: Centre Hospitalier Universitaire de Fort de France
state: Martinique
Study officials:
affiliation: Service de Médecine Interne - Centre Hospitalier Universiatire de Fort de France
name: Christophe DELIGNY, MD
role: PRINCIPAL_INVESTIGATOR
References: