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Hematological Parameters in Axial Spondyloarthritis

B

Bozyaka Training and Research Hospital

Status

Suspended

Conditions

Ankylosing Spondylitis

Treatments

Other: ASDAS-CRP
Other: BASDAI
Other: MASES
Other: ASDAS-ESR
Other: Systemic inflammatory index

Study type

Observational

Funder types

Other

Identifiers

NCT05450133
2022/PMR_AS

Details and patient eligibility

About

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.

Full description

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Diagnosed with axial spondyloarthritis according to the ASAS classification criteria

Exclusion criteria

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

Trial design

300 participants in 3 patient groups

R-ax-Spa
Description:
Radiographic axial spondyloarthritis
Treatment:
Other: Systemic inflammatory index
Other: ASDAS-ESR
Other: MASES
Other: BASDAI
Other: ASDAS-CRP
nR-ax-Spa
Description:
Non-radiographic axial spondyloarthritis
Treatment:
Other: Systemic inflammatory index
Other: ASDAS-ESR
Other: MASES
Other: BASDAI
Other: ASDAS-CRP
Control
Description:
Healthy Controls
Treatment:
Other: Systemic inflammatory index

Trial contacts and locations

1

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Central trial contact

Bugra Ince; Seniz Akcay

Data sourced from clinicaltrials.gov

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