Hematological Parameters in Axial Spondyloarthritis

NCT05450133 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-05-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Systemic inflammatory index

neutrophil count x platelet count/lymphocyte count

OTHER

BASDAI

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.

OTHER

ASDAS-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).

OTHER

ASDAS-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).

OTHER

MASES

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 & Collaborators

  • Bozyaka Training and Research Hospital

    lead OTHER

Principal Investigators

  • Bugra Ince · University of Health Sciences Izmir Bozyaka Training and Research Hospital

  • Seniz Akcay · University of Health Sciences Izmir Bozyaka Training and Research Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2026-02-15
Completion
2026-02-15

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05450133 on ClinicalTrials.gov