- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Martinique
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Fort de France, Martinique, Франция, 97261
- Centre Hospitalier Universitaire de Fort de France
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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.
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Frequency of hydrolase and DNase activities
Временное ограничение: 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)
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2 years
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Association of disease activity and catalytic activity
Временное ограничение: 2 years
|
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
|
Соавторы и исследователи
Следователи
- Главный следователь: Christophe DELIGNY, MD, Service de Médecine Interne - Centre Hospitalier Universiatire de Fort de France
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 10/E/12
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