NCT01157468已完成不适用
Study of Catalytic Antibodies in a Cohort Population of Martinique
University Hospital Center of Martinique1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Frequency of hydrolase and DNase activities
研究概览
简要总结
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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>
- •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
排除标准
- •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
结局指标
主要结局
Frequency of hydrolase and DNase activities
时间窗: 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)
次要结局
- Association of disease activity and catalytic activity(2 years)
研究者
研究点 (1)
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