NCT06094673

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

October 10, 2023

Last Update Submit

February 18, 2024

Conditions

Keywords

Ankylosing spondylitiscomplete blood countinflammation

Outcome Measures

Primary Outcomes (5)

  • 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.

    through study completion, an average of 1 month

  • Neutrophil-to-lymphocyte ratio (NLR)

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

    through study completion, an average of 1 month

  • Platelet to-lymphocyte ratio (PLR)

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

    through study completion, an average of 1 month

  • Mean platelet volume (MPV)

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

    through study completion, an average of 1 month

  • 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).

    through study completion, an average of 1 month

Secondary Outcomes (7)

  • C-reactive protein

    through study completion, an average of 1 month

  • Erythrocyte sedimentation rate

    through study completion, an average of 1 month

  • The Bath Ankylosing Spondylitis Disease Activity Index

    through study completion, an average of 1 month

  • The Bath Ankylosing Spondylitis Functional Index

    through study completion, an average of 1 month

  • The Bath Ankylosing Spondylitis Metrology Index

    through study completion, an average of 1 month

  • +2 more secondary outcomes

Interventions

No intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Therapy and Rehabilitation Research and Training Hospital

Istanbul, Bahcelievler, 34147, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Spondylitis, AnkylosingInflammation

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nur Kesiktas, MD, Prof

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 23, 2023

Study Start

June 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 2, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations