Skip to content

Hematological Parameters in Axial Spondyloarthritis

Relationship Between Systemic Inflammatory Index and Disease Activity in Axial Spondyloarthritis

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05450133
Enrollment
300
Registered
2022-07-08
Start date
2022-07-15
Completion date
2026-02-15
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis, Disease activity, Inflammatory marker

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.

Interventions

OTHERSystemic inflammatory index

neutrophil count x platelet count/lymphocyte count

OTHERBASDAI

Bath Ankylosing Spondylitis Disease Activity Index includes six questions which includes the following six parameters: fatigue, spinal pain, peripheral joint pain, attachment point inflammation, and duration and severity of morning stiffness. A total score, ranging from 0 to 10, was calculated according to the patients' responses to six questions, with a higher score indicating more severe illness.

OTHERASDAS-ESR

The ASDAS-ESR is deduced using formula that is chosen by the ASAS group. ASDAS-ESR is calculated with the answers of spinal, peripheral pain, morning stiffness on BASDAI, the patient global assessment, and erythrocyte sedimentation rate (mm/h).

OTHERASDAS-CRP

The ASDAS-CRP is deduced using formula that is chosen by the ASAS group. ASDAS-CRP is calculated with the answers of spinal, peripheral pain, morning stiffness on BASDAI, the patient global assessment, and erythrocyte C-reactive protein (mg/dl).

OTHERMASES

It is used to evaluate the sensitivity of enthesis points by palpation in patients with ankylosing spondylitis. Scoring is done by giving 1 point for sensitive areas and 0 points if there is no sensitivity on the fifth lumbar spinous process, bilateral first and seventh costochondral joints, iliac crystals, posterior and anterior iliac spines, attachment sites of achilles tendon to the calcaneus.

Sponsors

Bozyaka Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Systemic inflammatory indexBaselineneutrophils \* platelets/lymphocytes

Secondary

MeasureTime frameDescription
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)BaselineThe overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
Ankylosing Spondylitis Disease Activity Score (ASDAS)-ESRBaseline\<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)-CRPBaseline\<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.
Maastricht Ankylosing Spondylitis Entheses Score (MASES)BaselineMaastricht 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026