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
February 15, 2023
Primary Completion Date
February 15, 2023
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
January 2023