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Ankylosing SpondylitisNCT05450133

Hematological Parameters in Axial Spondyloarthritis

An observational study of Ankylosing Spondylitis, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Systemic inflammatory index, BASDAI and ASDAS-ESR
How many people
300 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jul 2022to 15 Feb 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • Diagnosed with axial spondyloarthritis according to the ASAS classification criteria

Who cannot join

  • Acute/chronic infections
  • Presence of other autoimmune diseases
  • Diabetes mellitus
  • Coronary arterial disease
  • Hypertension
  • Malignancy
Show all 10Show fewer
  • Hematological diseases
  • Liver diseases
  • Pregnancy/Lactation
  • Renal diseases

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Izmir Bozyaka Research and Training Hostpital

    Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Systemic inflammatory index, BASDAI, ASDAS-ESR, ASDAS-CRP, MASES
Keywords
Ankylosing Spondylitis, Disease activity, Inflammatory marker
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Systemic inflammatory indexOther

    neutrophil count x platelet count/lymphocyte count

  • BASDAIOther

    Also called Bath Ankylosing Spondylitis Disease Activity Index

    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.

  • ASDAS-ESROther

    Also called Ankylosing Spondylitis Disease Activity Score-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).

  • ASDAS-CRPOther

    Also called Ankylosing Spondylitis Disease Activity Score-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).

  • MASESOther

    Also called Maastricht Ankylosing Spondylitis Entheses Score

    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.

Study groups in NCT05450133
Study groupRoleWhat they receive
R-ax-SpaRadiographic axial spondyloarthritis
Receives: Other: Systemic inflammatory index; Other: BASDAI; Other: ASDAS-ESR; Other: ASDAS-CRP; Other: MASES
nR-ax-SpaNon-radiographic axial spondyloarthritis
Receives: Other: Systemic inflammatory index; Other: BASDAI; Other: ASDAS-ESR; Other: ASDAS-CRP; Other: MASES
ControlHealthy Controls
Receives: Other: Systemic inflammatory index

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systemic inflammatory index

    neutrophils * platelets/lymphocytes

    Measured: Baseline

Secondary outcomes (4)

  1. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.

    Measured: Baseline

  2. Ankylosing Spondylitis Disease Activity Score (ASDAS)-ESR

    <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".

    Measured: Baseline

  3. Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP

    <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".

    Measured: Baseline

  4. Maastricht Ankylosing Spondylitis Entheses Score (MASES)

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2022
  2. Study start15 Jul 2022
  3. Primary completion15 Feb 2026 (estimated)
  4. Study completion15 Feb 2026 (estimated)

Why it stopped: primary researcher is not avaible to recruit participants

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05450133
Sponsor's protocol ID
2022/PMR_AS
Status last verified
Apr 2025
First submitted
4 Jul 2022
Last updated
1 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It will be decided by the researchers.

Publications

  • 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.

    PubMed 31313609

  • 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.

    PubMed 27258203

  • 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.

    PubMed 26172961

  • 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.

    PubMed 32869876

  • 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.

    PubMed 34418163

Questions about this trial

What is this clinical trial studying?

An observational study of Ankylosing Spondylitis, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systemic inflammatory index (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05450133, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.

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