Hematological Parameters in Axial Spondyloarthritis

NCT05450133 | Suspended

• 1 other identifier: 2022/PMR_AS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis; Disease activity; Inflammatory marker

Outcome Measures

Primary Outcomes (1)

• Systemic inflammatory index

  neutrophils \* platelets/lymphocytes

  Baseline

Secondary Outcomes (4)

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Baseline

• Ankylosing Spondylitis Disease Activity Score (ASDAS)-ESR

  Baseline

• Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP

  Baseline

• Maastricht Ankylosing Spondylitis Entheses Score (MASES)

  Baseline

Study Arms (3)

R-ax-Spa

Radiographic axial spondyloarthritis

Other: Systemic inflammatory index; Other: BASDAI; Other: ASDAS-ESR; Other: ASDAS-CRP; Other: MASES

nR-ax-Spa

Non-radiographic axial spondyloarthritis

Other: Systemic inflammatory index; Other: BASDAI; Other: ASDAS-ESR; Other: ASDAS-CRP; Other: MASES

Control

Healthy Controls

Other: Systemic inflammatory index

Interventions

Systemic inflammatory index OTHER

neutrophil count x platelet count/lymphocyte count

Control; R-ax-Spa; nR-ax-Spa

BASDAI OTHER

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.

Also known as: Bath Ankylosing Spondylitis Disease Activity Index

R-ax-Spa; nR-ax-Spa

ASDAS-ESR OTHER

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).

Also known as: Ankylosing Spondylitis Disease Activity Score-ESR

R-ax-Spa; nR-ax-Spa

ASDAS-CRP OTHER

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).

Also known as: Ankylosing Spondylitis Disease Activity Score-CRP

R-ax-Spa; nR-ax-Spa

MASES OTHER

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.

Also known as: Maastricht Ankylosing Spondylitis Entheses Score

R-ax-Spa; nR-ax-Spa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosed with axial spondyloarthritis according to the ASAS classification criteria

You may not qualify if:

• Acute/chronic infections
• Presence of other autoimmune diseases
• Diabetes mellitus
• Coronary arterial disease
• Hypertension
• Malignancy
• Hematological diseases
• Liver diseases
• Pregnancy/Lactation
• Renal diseases

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Research and Training Hostpital

Izmir, Turkey (Türkiye)

Location

Related Publications (5)

• Song GG, Lee YH. Red cell distribution width, platelet-to-lymphocyte ratio, and mean platelet volume in ankylosing spondylitis and their correlations with inflammation: A meta-analysis. Mod Rheumatol. 2020 Sep;30(5):894-899. doi: 10.1080/14397595.2019.1645373. Epub 2019 Aug 1.

  PMID: 31313609 BACKGROUND

• Sezgin M, Tecer D, Kanik A, Kekik FS, Yesildal E, Akaslan E, Yildirim G, Sahin G. Serum RDW and MPV in Ankylosing Spondylitis: Can they show the disease activity? Clin Hemorheol Microcirc. 2017;65(1):1-10. doi: 10.3233/CH-162067.

  PMID: 27258203 BACKGROUND

• Malaviya AN, Kalyani A, Rawat R, Gogia SB. Comparison of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) from a single rheumatology clinic in New Delhi. Int J Rheum Dis. 2015 Sep;18(7):736-41. doi: 10.1111/1756-185X.12579. Epub 2015 Jul 14.

  PMID: 26172961 BACKGROUND

• Tanacan E, Dincer D, Erdogan FG, Gurler A. A cutoff value for the Systemic Immune-Inflammation Index in determining activity of Behcet disease. Clin Exp Dermatol. 2021 Mar;46(2):286-291. doi: 10.1111/ced.14432. Epub 2020 Oct 10.

  PMID: 32869876 BACKGROUND

• Wu J, Yan L, Chai K. Systemic immune-inflammation index is associated with disease activity in patients with ankylosing spondylitis. J Clin Lab Anal. 2021 Sep;35(9):e23964. doi: 10.1002/jcla.23964. Epub 2021 Aug 21.

  PMID: 34418163 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Bugra Ince

  University of Health Sciences Izmir Bozyaka Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Seniz Akcay

  University of Health Sciences Izmir Bozyaka Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Specialist

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: July 15, 2022
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

TU (1)