Catalytic Antibodies and Lupus in Martinique (LUMAB2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Centre Hospitalier Universitaire de Fort-de-France.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier:
NCT01157468
First received: July 5, 2010
Last updated: July 6, 2010
Last verified: July 2010
  Purpose
  • 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.

Condition
Systemic Lupus Erythematosus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of Catalytic Antibodies in a Cohort Population of Martinique

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Fort-de-France:

Primary Outcome Measures:
  • Frequency of hydrolase and DNase activities [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Association of disease activity and catalytic activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the strength of the association of disease activity and catalytic activity of antibodies (quiescent / active and control / patient)


Biospecimen Retention:   Samples With DNA
  • For the "case" means the research will be done on a blood sample of 7 ml, reclassified from treatement to research, collected from the blood sampling usually prescribed by doctors to treat the patient come to be diagnosed a lupus or for continuing care.
  • For the "control" means research will be done on a blood sample of 7 ml collected from people coming to donate blood at thethe French Blood Establishment of Martinique.

The volume does not exceed the maximum amount allowed by French regulations for blood donation.


Estimated Enrollment: 180
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cases

The "Case" group is constituted with patients with Systemic Lupus Erythematosus from Martinique, divided en 2:

  • 30 patients with a quiescent lupus
  • 30 patients with an active lupus
Controles
The "Control" group is constituted by people coming to give blood to the French Blood Establishment of Martinique.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157468

Contacts
Contact: Christophe DELIGNY, MD +596 596 55 22 55 christophe.deligny@chu-fortdefrance.fr
Contact: Véronique ERDUAL, Master +596 596 592 698 veronique.erdual@chu-fortdefrance.fr

Locations
France
Centre Hospitalier Universitaire de Fort de France
Fort de France, Martinique, France, 97261
Sponsors and Collaborators
Centre Hospitalier Universitaire de Fort-de-France
Investigators
Principal Investigator: Christophe DELIGNY, MD Service de Médecine Interne - Centre Hospitalier Universiatire de Fort de France
  More Information

No publications provided

Responsible Party: Mr Daniel RIAM, General Director, Centre Hospitalier Universitaire de Fort de France
ClinicalTrials.gov Identifier: NCT01157468     History of Changes
Other Study ID Numbers: 10/E/12
Study First Received: July 5, 2010
Last Updated: July 6, 2010
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre Hospitalier Universitaire de Fort-de-France:
Systemic Lupus Erythematosus in Martinique
Hydrolase and DNase activities

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014