Clinical Follow-up of Anti-Carbamylated Antibody Status in Rheumatoid Arthritis Patients at 6, 12 and 18 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- DAS28-ESR
研究概览
简要总结
Patients with rheumatoid arthritis (RA) with positive antibodies against carbamylated proteins (anti-CarP) have a more severe clinical course. The primary objective of this study in adult subject with RA is as follows: To explore the clinical differences in activity indexes (Disease Activity Score of 28 joints with Erythro Sedimentaion Rate (DAS28-ESR)) at 6, 12 and 18 months of follow up according the anti-CarP antibodies status.
详细描述
Clinical follow-up of Anti-Carbamylated Antibody Status in Rheumatoid Arthritis patients at 6, 12 and 18 months.
Concept
Patients with rheumatoid arthritis (RA) with positive antibodies against carbamylated proteins (anti-CarP) have a more severe clinical course.
Background
The immune based pathophysiology of RA is one of the most studied. We already know that the citrullinated peptide antigen inducing antibody formation and subsequent anti-cyclic citrullinated peptide (anti-CCP) antibodies. In some patients can explain the clinical manifestations. However it is also apparent that some groups of patients with rheumatoid arthritis who do not have anti-CCP antibodies. It is possible then the presence of a variety of antigens exposed during the disease, and perhaps different clinical presentations associated with each.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Rheumatoid arthritis patients according to ACR EULAR 2010 classification that accepted and signed informed consent
排除标准
- •Chronic kidney disease and pregnant patients
结局指标
主要结局
DAS28-ESR
时间窗: 6, 12 and 18 Months
To explore the clinical differences in activity indexes (DAS28-ESR) at 6, 12 and 18 months of follow-up according the anti-CarP status. The DAS28 is a composite score derived from 4 measures, one of them can be the erythrocyte sedimentation rate (ESR). We will be using the DAS28-ESR version. To calculate the DAS28-ESR the rheumatologist or specialist nurse will:- count the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure ESR, ask participants to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28-ESR is calculated with classic calculators and resulting values are interpreted as follows: \<2.6: disease remission 2.6 - 3.2: low disease activity 3.2 - 5.1: moderate disease activity \>5.1: high disease activity
次要结局
未报告次要终点
研究者
David Vega Morales
MD, MsSc, Doctorate
Universidad Autonoma de Nuevo Leon