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临床试验/NCT04095169
NCT04095169已完成不适用

Biomarkers in Early-stage Spondyloarthritis

Spine Centre of Southern Denmark0 个研究点目标入组 216 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
216
主要终点
C3d levels

研究概览

简要总结

Axial spondyloarthritis (axSpA) is a group of inflammatory rheumatic conditions with inflammatory back pain caused by inflammation in the sacroiliac joints (SIJ) and back as hallmark.

Currently, no laboratory test or biomarker is cable of differentiating between patients with early-stage axSpA and persisting low back pain of other causes.

The objective of this study is to investigate the predictive value of baseline levels of the biomarkers Complement C3d and high-sensitive C-reactive protein (HsCRP) identifying bone marrow oedema (BME) at MRI of the SIJ at baseline.

详细描述

Currently, no laboratory test or biomarker is cable of differentiating between patients with early-stage axSpA and persisting low back pain of other causes. Human leukocyte antigen (HLA) B27 is not an acute biomarker, but a prognostic marker for the development of axSpA.

C-reactive protein (CRP) is commonly used as an acute biomarker in different inflammatory conditions. Previous studies have shown that only 40-60% of ankylosing spondylitis (AS) patients with clinical signs of active disease have elevated levels of CRP.

Earlier studies regarding the complement C3 split product C3d have shown a correlation between inflammatory diseases like AS and elevation of C3d. Those studies were based on a small number of cases, but a newer study from 2016 has shown a correlation between different biomarkers, including C3 and new fatty lesions at MRI in Golimumab treated AS patients.

Objective To investigate the predictive value of baseline levels of C3d and hsCRP identifying bone marrow oedema (BME) at MRI of the sacroiliac joints (SIJ) at baseline.

Design:

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

C3d levels

时间窗: 1 month after sampling of C3d

Baseline levels of C3d between 3 groups

次要结局

  • MRI changes(3 months after sampling of C3d)

研究者

发起方
Spine Centre of Southern Denmark
申办方类型
Other
责任方
Sponsor

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