Hematological Parameters in Axial Spondyloarthritis

September 1, 2023 updated by: Buğra İnce, Bozyaka Training and Research Hospital

Relationship Between Systemic Inflammatory Index and Disease Activity in Axial Spondyloarthritis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • İzmir, Turkey
        • Recruiting
        • Izmir Bozyaka Research and Training Hostpital
        • Contact:
          • BUGRA INCE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Radiographic and non-radiographic axial spondyloarthritis subjects and healthy volunteers will be invited to the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
R-ax-Spa
Radiographic axial spondyloarthritis
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 Names:
  • Bath Ankylosing Spondylitis Disease Activity Index
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 Names:
  • Ankylosing Spondylitis Disease Activity Score-ESR
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 Names:
  • Ankylosing Spondylitis Disease Activity Score-CRP
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.
Other Names:
  • Maastricht Ankylosing Spondylitis Entheses Score
nR-ax-Spa
Non-radiographic axial spondyloarthritis
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 Names:
  • Bath Ankylosing Spondylitis Disease Activity Index
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 Names:
  • Ankylosing Spondylitis Disease Activity Score-ESR
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 Names:
  • Ankylosing Spondylitis Disease Activity Score-CRP
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.
Other Names:
  • Maastricht Ankylosing Spondylitis Entheses Score
Control
Healthy Controls
Other: Systemic inflammatory index
neutrophil count x platelet count/lymphocyte count

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic inflammatory index
Time Frame: Baseline
neutrophils * platelets/lymphocytes
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: Baseline
The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
Baseline
Ankylosing Spondylitis Disease Activity Score (ASDAS)-ESR
Time Frame: 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".
Baseline
Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP
Time Frame: 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".
Baseline
Maastricht Ankylosing Spondylitis Entheses Score (MASES)
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozyaka Training and Research Hospital

Investigators

  • Principal Investigator: Bugra Ince, University of Health Sciences Izmir Bozyaka Training and Research Hospital
  • Study Director: Seniz Akcay, University of Health Sciences Izmir Bozyaka Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Estimated)

February 15, 2024

Study Completion (Estimated)

February 15, 2024

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

July 4, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/PMR_AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It will be decided by the researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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