Hematological Parameters in Axial Spondyloarthritis

Brief Title

Hematological Parameters in Axial Spondyloarthritis

Official Title

Relationship Between Systemic Inflammatory Index and Disease Activity in Axial Spondyloarthritis

Brief Summary

      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.
    

Detailed 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.
    


Study Type

Observational


Primary Outcome

Systemic inflammatory index

Secondary Outcome

 Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Condition

Ankylosing Spondylitis

Intervention

Systemic inflammatory index

Study Arms / Comparison Groups

 R-ax-Spa
Description:  Radiographic axial spondyloarthritis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

300

Start Date

July 15, 2022

Completion Date

August 15, 2022

Primary Completion Date

August 15, 2022

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Bugra Ince, 05301552736, [email protected]

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT05450133

Organization ID

2022/PMR_AS


Responsible Party

Principal Investigator

Study Sponsor

Bozyaka Training and Research Hospital


Study Sponsor

Bugra Ince, Principal Investigator, University of Health Sciences Izmir Bozyaka Training and Research Hospital


Verification Date

July 2022