跳至主要内容
临床试验/NCT05450133
NCT05450133暂停不适用

Relationship Between Systemic Inflammatory Index and Disease Activity in Axial Spondyloarthritis

Bozyaka Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
300
试验地点
1
主要终点
Systemic inflammatory index

研究概览

简要总结

Axial spondyloarthritis is an inflammatory disease characterized by the involvement of the sacroiliac joints and the spine. Disease activity and structural changes are determined by using physical examination, imaging studies, laboratory parameters, and patient-reported indices. Among laboratory studies, Erythrocyte sedimentation rate (ESR) and c-reactive protein (CRP) are the most commonly utilized parameters. However, the level of ESR and CRP are inadequate in demonstrating disease activity and inflammation compared to other diseases. In this study, the investigators aimed to analyze and compare the systemic inflammatory index (SII), which is a hematologic parameter between subjects with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, and healthy controls. Secondarily, the relationship between disease activity and enthesitis score and SII scores in patients with radiographic and non-radiographic axial spondyloarthritis will be investigated.

详细描述

Axial spondyloarthritis is an inflammatory disease characterized by the involvement of the sacroiliac joints and the spine. Disease activity and structural changes are determined by using physical examination, imaging studies, laboratory parameters, and patient-reported indices. Among laboratory studies, Erythrocyte sedimentation rate (ESR) and c-reactive protein (CRP) are the most commonly utilized parameters. ESR and CRP are within the normal range in 40-50% of patients with spondyloarthritis and may remain within the normal range even during active disease. Therefore, the use of biomarkers suitable for the pathophysiology of the disease have been recommended. However, these tests are difficult to access and there is no consensus on showing disease activity. Systemic inflammatory index (SII) is a novel hematologic parameter and previous studies reported the relationship with disease activity in rheumatologic diseases, but the results are inconsistent.

This study will compare the SII between subjects with radiographic and non-radiographic axial spondyloarthritis with healthy subjects. Secondly, the study will investigate the relationship between SII, a new inflammation parameter, and disease activity in patients diagnosed with radiographic and non-radiographic axial spondyloarthritis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with axial spondyloarthritis according to the ASAS classification criteria

排除标准

  • Acute/chronic infections
  • Presence of other autoimmune diseases
  • Diabetes mellitus
  • Coronary arterial disease
  • Hypertension
  • Malignancy
  • Hematological diseases
  • Liver diseases
  • Pregnancy/Lactation
  • Renal diseases

结局指标

主要结局

Systemic inflammatory index

时间窗: Baseline

neutrophils \* platelets/lymphocytes

次要结局

  • Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP(Baseline)
  • Ankylosing Spondylitis Disease Activity Score (ASDAS)-ESR(Baseline)
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline)
  • Maastricht Ankylosing Spondylitis Entheses Score (MASES)(Baseline)

研究者

发起方
Bozyaka Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Buğra İnce

Medical Doctor, Specialist

Bozyaka Training and Research Hospital

研究点 (1)

Loading locations...

相似试验

Hematological Parameters in Axial Spondyloarthritis | 临床试验