Clinical trial NCT05450133: Hematological Parameters in Axial Spondyloarthritis
Official title: Relationship Between Systemic Inflammatory Index and Disease Activity in Axial Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Disease activity
Inflammatory marker
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Radiographic and non-radiographic axial spondyloarthritis subjects and healthy volunteers will be invited to the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systemic inflammatory index
timeFrame: Baseline
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)-ESR
timeFrame: Baseline
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP
timeFrame: Baseline
measure: Maastricht Ankylosing Spondylitis Entheses Score (MASES)
timeFrame: Baseline
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Bozyaka Research and Training Hostpital
Study officials:
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Bugra Ince
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Seniz Akcay
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.