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Ankylosing SpondylitisNCT06094673

The Relationship Between Systemic Immune Inflammation Index and Disease Activity in Patients With Ankylosing Spondylitis

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, the aim was to investigate the relationship between SII and other laboratory parameters with disease activity in AS patients and to discuss its usability in the follow-up and treatment process. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ankylosing Spondylitis
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2023to 2 Jul 2023
How long will I take part?
1 Day
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients between the ages of 18 and 65 who have been diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria

Who may be able to join

  • Patients between the ages of 18 and 65 who have been diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria, have applied to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital outpatient clinic on the specified dates, meet the exclusion criteria, and have complete blood count, CRP, and ESR values in their hospital records.

Who cannot join

  • Presence of acute or chronic infection
  • Presence of autoimmune diseases other than Ankylosing Spondylitis
  • Pregnancy
  • Diabetes
  • Chronic kidney disease
  • Chronic liver disease
Show all 9Show fewer
  • Malignancy
  • Cardiovascular disease
  • Hematological disease

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Physical Therapy and Rehabilitation Research and Training Hospital

    Istanbul, Bahcelievler, 34147

Other trials in Turkey (Türkiye)

About this study

In this study, the aim was to investigate the relationship between SII and other laboratory parameters with disease activity in AS patients and to discuss its usability in the follow-up and treatment process.

Read the detailed description

This study aimed to investigate the relationship between the systemic immune inflammation index (SII), platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and disease activity and functional status in patients with ankylosing spondylitis (AS). A cross-sectional clinical study was conducted, and a total of 90 patients diagnosed with AS according to the Modified New York Criteria, aged between 18 and 65, who presented to our outpatient clinics were included in the study. Demographic data, disease duration, age at symptom onset, and laboratory parameters, including platelet, neutrophil, basophil, eosinophil, lymphocyte counts, mean platelet volume (MPV), red blood cell distribution width (RDW), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR), were recorded. NLR and PLR values were calculated. The Systemic Immune Inflammation Index (SII) was calculated by dividing the product of neutrophil and platelet counts by the lymphocyte count. We investigated all of these parameters and disease activity scores. Disease activity was assessed with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), spinal mobility with the Bath Ankylosing Spondylitis Metrology Index (BASMI), and functional status with the Bath Ankylosing Spondylitis Functional Index (BASFI). In addition, during the routine follow-ups of patients, requested blood tests were examined, and platelet, neutrophil, basophil, eosinophil, lymphocyte counts, mean platelet volume (MPV), RDW (red blood distribution width), CRP, and ESR values will be recorded. Neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), and systemic immune inflammation index (SII) were calculated

Being tested
No intervention
Keywords
Ankylosing spondylitis, complete blood count, inflammation
Medical subject headings
Spondylitis, Ankylosing, Inflammation

What participants receive

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

  • No interventionOther

    No intervention

What is being measured

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

  1. The Systemic Immune Inflammation Index (SII)

    The Systemic Immune Inflammation Index (SII) was calculated by dividing the product of neutrophil and platelet counts by the lymphocyte count.

    Measured: through study completion, an average of 1 month

  2. Neutrophil-to-lymphocyte ratio (NLR)

    NLR is a ratio between the absolute neutrophil count and absolute lymphocyte count.

    Measured: through study completion, an average of 1 month

  3. Platelet to-lymphocyte ratio (PLR)

    PLR is a ratio between the absolute platelet count and absolute lymphocyte count.

    Measured: through study completion, an average of 1 month

  4. Mean platelet volume (MPV)

    MPV blood test measures the average size of patient's platelets

    Measured: through study completion, an average of 1 month

  5. Red blood cell distribution width (RDW)

    A red cell distribution width (RDW) test measures the differences in the volume and size of the red blood cells (erythrocytes).

    Measured: through study completion, an average of 1 month

Secondary outcomes (7)

  1. C-reactive protein

    C-reactive protein (CRP) is a protein made by the liver. The level of CRP increases when there's inflammation in the body.

    Measured: through study completion, an average of 1 month

  2. Erythrocyte sedimentation rate

    The erythrocyte sedimentation rate (sedimentation rate, sed rate, or ESR for short) is a commonly performed hematology test that may indicate and monitor an increase in inflammatory activity within the body caused by one or more conditions such as autoimmune disease, infections, or tumors

    Measured: through study completion, an average of 1 month

  3. The Bath Ankylosing Spondylitis Disease Activity Index

    The index indicates that disease activity of AS patients. Higher scores indicate that higher activity

    Measured: through study completion, an average of 1 month

  4. The Bath Ankylosing Spondylitis Functional Index

    The index helps to evaluate disease activity of AS patients. High scores indicate that worse functional status.

    Measured: through study completion, an average of 1 month

  5. The Bath Ankylosing Spondylitis Metrology Index

    The index helps to evaluate spinal mobility of AS patients. Higher scores indicate more limited mobility.

    Measured: through study completion, an average of 1 month

  6. Ankylosing Spondylitis Disease Activity Score with erythrocyte sedimentation rate

    it helps to evaluate disease activity of AS patients by used to esr

    Measured: through study completion, an average of 1 month

  7. Ankylosing Spondylitis Disease Activity Score with c-reactive protein

    it helps to evaluate disease activity of AS patients by used to crp

    Measured: through study completion, an average of 1 month

Timeline

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

  1. First posted23 Oct 2023
  2. Study start1 Jun 2023
  3. Primary completion1 Jul 2023
  4. Study completion2 Jul 2023

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
90 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06094673
Sponsor's protocol ID
IstPRMTRH4
Status last verified
Feb 2024
First submitted
10 Oct 2023
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Liang T, Chen J, Xu G, Zhang Z, Xue J, Zeng H, Jiang J, Chen T, Qin Z, Li H, Ye Z, Nie Y, Zhan X, Liu C. Platelet-to-Lymphocyte Ratio as an Independent Factor Was Associated With the Severity of Ankylosing Spondylitis. Front Immunol. 2021 Nov 5;12:760214. doi: 10.3389/fimmu.2021.760214. eCollection 2021.

    PubMed 34804047

  • Choe JY, Lee CU, Kim SK. Association between Novel Hematological Indices and Measures of Disease Activity in Patients with Rheumatoid Arthritis. Medicina (Kaunas). 2023 Jan 6;59(1):117. doi: 10.3390/medicina59010117.

    PubMed 36676741

  • Satis S. New Inflammatory Marker Associated with Disease Activity in Rheumatoid Arthritis: The Systemic Immune-Inflammation Index. Curr Health Sci J. 2021 Oct-Dec;47(4):553-557. doi: 10.12865/CHSJ.47.04.11. Epub 2021 Dec 31.

    PubMed 35444819

  • Seng JJB, Kwan YH, Low LL, Thumboo J, Fong WSW. Role of neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR) and mean platelet volume (MPV) in assessing disease control in Asian patients with axial spondyloarthritis. Biomarkers. 2018 May-Jun;23(4):335-338. doi: 10.1080/1354750X.2018.1425916. Epub 2018 Jan 24.

    PubMed 29307233

Questions about this trial

What is this clinical trial studying?

An observational study of Ankylosing Spondylitis, run by Istanbul Physical Medicine Rehabilitation 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 9 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: finished, as of the sponsor's last update on 20 Feb 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The Systemic Immune Inflammation Index (SII) (time frame: through study completion, an average of 1 month). The study lists 5 primary outcomes in all. 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 NCT06094673, 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 20 Feb 2024; AzTrials last refreshed its copy on 2 Nov 2026.

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