- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01157468
Catalytic Antibodies and Lupus in Martinique (LUMAB2)
Study of Catalytic Antibodies in a Cohort Population of 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Martinique
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Fort de France, Martinique, France, 97261
- Centre Hospitalier Universitaire de Fort de France
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Cases
The "Case" group is constituted with patients with Systemic Lupus Erythematosus from Martinique, divided en 2:
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Controles
The "Control" group is constituted by people coming to give blood to the French Blood Establishment of Martinique.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Frequency of hydrolase and DNase activities
Délai: 2 years
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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)
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2 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Association of disease activity and catalytic activity
Délai: 2 years
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Evaluate the strength of the association of disease activity and catalytic activity of antibodies (quiescent / active and control / patient)
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2 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Christophe DELIGNY, MD, Service de Médecine Interne - Centre Hospitalier Universiatire de Fort de France
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10/E/12
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Essais cliniques sur Le lupus érythémateux disséminé
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University of Alabama at BirminghamRésiliéLymphome anaplasique à grandes cellules | Lymphome T angio-immunoblastique | Lymphomes T périphériques | Leucémie à cellules T de l'adulte | Lymphome T adulte | Lymphome T périphérique Non précisé | T/Null Cell Systemic Type | Lymphome cutané à cellules T avec maladie nodale/viscéraleÉtats-Unis