Hematological Parameters in Axial Spondyloarthritis

Suspended

• Conditions: Ankylosing Spondylitis
• Interventions: Other: Systemic inflammatory index; Other: BASDAI; Other: ASDAS-ESR; Other: ASDAS-CRP; Other: MASES

• Registration Number: NCT05450133
• Lead Sponsor: Bozyaka Training and Research Hospital

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 Timeline

• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-08
• Study Start: 2022-07-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-02-15
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Systemic inflammatory index	Baseline	neutrophils \* platelets/lymphocytes

Secondary Outcome Measures

Name	Time	Method
Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP	Baseline	\<1.3 between "inactive disease" and "low disease activity", \<2.1 between "moderate disease activity" and "high disease activity", and \>3.5 between "high disease activity" and "very high disease activity".
Ankylosing Spondylitis Disease Activity Score (ASDAS)-ESR	Baseline	\<1.3 between "inactive disease" and "low disease activity", \<2.1 between "moderate disease activity" and "high disease activity", and \>3.5 between "high disease activity" and "very high disease activity".
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Baseline	The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
Maastricht Ankylosing Spondylitis Entheses Score (MASES)	Baseline	Maastricht Ankylosing Spondylitis Entheses Score MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Negative values indicate better outcome.

Trial Locations

Locations (1)

Izmir Bozyaka Research and Training Hostpital; 🇹🇷 İzmir, Turkey