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临床试验 NCT06594107 (EISPA) 针对轴性脊柱关节炎目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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Factors for the Onset and Course of Axial Spondylitis (EISPA)

招募中
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临床试验NCT06594107 (EISPA)是一项针对轴性脊柱关节炎观察研究试验,目前试验状态为招募中。试验始于2022年9月1日,计划招募1,000名患者。该研究由卡罗琳学院主导,预计于2035年12月31日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2024年9月24日
简要概括
In a research project, investigators want to study the course of the disease of axial spondylitis: the causes of disease onset, prognosis, and treatment effects. The goal is to improve treatment and in the long run also prevention of the disease. The project has a focus on the body's own substance prostaglandin, and its proinflammatory role in spondylitis, but also other substances may be analyzed in blood and urine samples.

The purpose of the research project is include newly diagnosed treatment-naive patients with axial spondyloarthritis, to follow them after 1 and 2 years after treatment start, to collect clinical data, questionnaires, blood and urinsamples to find blood or urine markers that can be used for precision therapy of axial spondylitis.

详细描述
The EISPA study is an epidemiological and translational study in axial spondylitis patients who are included in the Swedish Rheumatology Quality Register (SRQ). EISPA aims to include consecutive newly diagnosed axial spondylitis patients.

Despite the fact that the disease is relatively common, it takes on average 10 years after start of symptoms for patients be diagnosed with axial spondylitis.

Axial spondylitis diagnosis is based on clinical findings rather than diagnostic tests, which reflects lack of knowledge about what causes the disease. At present, our possibilities to predict the course of the disease (and thereby individualize the care of the patient) are limited. Current treatment decreases inflammation rather than treating the cause of the disease.

The first treatment step of axial spondylitis is with non-steroidal anti-inflammatory drugs or COX inhibitors, which usually have insufficient effect against inflammatory pain and stiffness. In addition, these drugs are associated with side effects, such as gastrointestinal and cardiovascular side effects. Axial spondylitis is a multifactorial disease where the arachidonic acid cascade, an increased prostaglandin production and release may play a major role. With this there is a clear potential to develop new specific drugs to slow down the prostaglandin cascade in patients with axial spondylitis.

官方标题

Faktorer För Uppkomst Och Förlopp Av Axial Spondylartrit

疾病
轴性脊柱关节炎
出版物
关于此临床试验发表的科学文章和研究论文:
其他研究标识符
  • EISPA
  • 2022-01789-01 (其他标识符) (Karolinska Institute and University Hospital)
NCT编号
实际开始日期
2022-09-01
最近更新发布
2024-09-24
预计完成日期
2035-12-31
计划入组人数
1,000
研究类型
观察研究
试验状态
招募中
关键词
observational
axial spondyloarthritis
prostaglandins
predictive factors
试验组/干预措施
参与者组/试验组干预措施/治疗方法
1 cohort at Karolinska University Hospital and 1 at the Center for Rheumatology in Stockholm
This cohortstudy is performed at 2 sites.
不适用
主要终点
结果指标度量标准描述时间框架
Prostaglandin levels
Investigators measure prostaglandin levels in treatment-naïve patients at baseline, and then after therapy start after 1 and 2 years.
2 years
次要终点
结果指标度量标准描述时间框架
Questionnaires
Investigators collect data on modifiable environmental factors and lifestyle that may contribute to the onset of the disease.
2 years
Clinical data
Investigators collect clinical data as entered in the Swedish Rheumatology Quality Register (SRQ) plus the ASAS-health index (0-17, with a lower score indicating a better health status), such as inflammatory markers ESR (mm/hour)/CRP (mg/l), and other variables in the ASAS core outcome set for all trials as defined by ASAS-Omeract.
2 years
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
  • newly diagnosed patients with axial spondyloarthritis
  • treatment-naive
  • 18 years of age or older
  • Swedish-speaking
  • Able to give informed consent

  • DMARD treatment,
  • ongoing infection
  • ongoing malignancy
Karolinska Institutet logo卡罗琳学院
Karolinska University Hospital logoKarolinska University Hospital
研究责任方
Per-Johan Jakobsson, 主要研究者, MD PhD Professor, Karolinska Institutet
研究中心联系人
联系人: Per-Johan Jakobsson, MD PhD Professor, 0725848033, [email protected]
2 位于 1 个国家/地区的研究中心

Stockholm County

Karolinska University Hospital, Huddinge, Stockholm County, 141 86, Sweden
Mirjam K de Vries, MD PhD, 联系人, 0725948031, [email protected]
Sara Brolin, Research nurse, 联系人, 0046724682252, [email protected]
Mirjam K de Vries, MD PhD, 联系人
招募中
Center for Rheumatology Stockholm, Stockholm, Stockholm County, 113 65, Sweden
Marika K Kvarnström, MD PhD, 联系人, 0812367650, [email protected]
Zoja Holgersson, Research nurse, 联系人, 0812367650, [email protected]
Marika Kvarnström, MD PhD, 联系人
招募中