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临床试验/NCT02809300
NCT02809300Unknown不适用

Prevalence of Antiphospholipid Antibodies in Ankylosing Spondylitis: A Study of 80 Patients

CHU de Reims1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
CHU de Reims
入组人数
80
试验地点
1
主要终点
presence or absence of APLA

研究概览

简要总结

The main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in patients with ankylosing spondylitis (AS).

The secondary objectives are: (1) To determine whether the presence of these antibodies is symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence of APLA and a particular form of SA (axial or peripheral); (3) To determine whether the presence of APLA is more frequent in patients receiving anti-tumor necrosis factor (TNF) alpha therapy.

详细描述

Methods:

Experimental design: longitudinal study prospective in a single center.

The Ankylosing Spondylitis Assesment Study (ASAS) criteria are: (1) age <45 years, back pain ≥ 3 months, sacroiliitis on imaging and ≥ 1 associated minor criterion, or (2) HLA B27 positive and ≥ 2 minor criteria.

Minor criteria are: inflammatory back pain, arthritis, enthesitis, uveitis, Dactylitis, psoriasis, Crohn's disease, good clinical response to NSAIDs, family history of Human Leukocyte Antigen HLA B27 and inflammatory syndrome.

Plan Investigation:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • •older than 18 years
  • •with SA according to ASAS criteria
  • •followed in the Internal Medicine Department of the REIMS University Hospital
  • •who have given their consent
  • •affiliated to social security insurance

排除标准

  • •minor patients
  • •patients with autoimmune disease (except the inflammatory bowel disease)
  • •coagulation disorders
  • •anticoagulant treatment (anticoagulation out for events history thrombus embolism)
  • •pregnant women
  • •patients protected by law

研究组 & 干预措施

ankylosing spondylarthritis

Experimental

干预措施: blood collection (Biological)

结局指标

主要结局

presence or absence of APLA

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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