Catalytic Antibodies and Lupus in Martinique

Systemic Lupus Erythematosus Clinical Trial

— LUMAB2  

Official title:

Study of Catalytic Antibodies in a Cohort Population of Martinique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157468
• Other study ID #: 10/E/12
• Status: Completed
• Phase: N/A
• First received: July 5, 2010
• Last updated: September 7, 2016
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2016
• Source: University Hospital Center of Martinique
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Fort de France	Fort de France	Martinique

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of hydrolase and DNase activities	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)	2 years	No
Secondary	Association of disease activity and catalytic activity	Evaluate the strength of the association of disease activity and catalytic activity of antibodies (quiescent / active and control / patient)	2 years	No