NCT05914532

Brief Summary

investigators aimed to evaluate the relationship between Systemic Immune Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) and disease activity in patients with axial spondyloarthropathy (SpA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

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

First Submitted

Initial submission to the registry

June 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 22, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

18 days

First QC Date

June 10, 2023

Last Update Submit

August 21, 2023

Conditions

Keywords

Axial SpondyloarthritisSystemic Immune Inflammation IndexSystemic Inflammation Response Index

Outcome Measures

Primary Outcomes (1)

  • Comparison of SIRI and SII between Patient and Healthy Control

    SIRI= neutrophil count\*monocyte count/lymphocyte count and SII= neutrophil count\*platelet count/lymphocyte count.

    Baseline

Secondary Outcomes (1)

  • Correlation analysis of SIRI and SII with scales and laboratory findings

    Baseline

Study Arms (2)

group 1

healthy controls

Other: lab testing

group 2

axial spondyloarthropathy

Other: lab testing

Interventions

Complete blood count and erythrocyte sedimentation rate and C-reactive protein values of the participants were analyzed by laboratory test.

group 1group 2

Eligibility Criteria

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

Group 1:healthy controls working in our hospital, Group 2: SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria

You may qualify if:

  • SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria
  • healthy controls working in our hospital,

You may not qualify if:

  • infections, coronary artery disease, kidney and liver dysfunction, cancer diagnosis, surgery in the last three months, diabetes mellitus diagnosis, hypertension and pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Resarch Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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: 34418163BACKGROUND

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • Burak Tayyip DEDE, MD

    İstanbul Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

June 10, 2023

First Posted

June 22, 2023

Study Start

June 22, 2023

Primary Completion

July 10, 2023

Study Completion

August 10, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations