New Biomarkers in Axial Sypondyloarthropathy; SII and SIRI

Axial Spondyloarthritis Clinical Trial

Official title:

In Patients With Axial Spondyloarthropathy; Evaluation of the Relationship Between the Systemic Immune Inflammation Index and the Systemic Inflammatory Response Index With Disease Activity and Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05914532
• Other study ID #: 19/08/2022, 2011-KAEK-50: 262
• Status: Completed
• Start date: June 22, 2023
• Est. completion date: August 10, 2023

Study information

• Verified date: August 2023
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

The clinical characteristics and laboratory data of the patients and healthy controls participating in our study were obtained through the hospital system. Then, the new biomarkers SIRI and SII values were calculated. SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count. Then, SIRI and SII values were compared between groups. The relationship between disease activity and SIRI and SII values in the patient group was examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: August 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria

• 51 healthy controls working in our hospital,

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul Training and Resarch Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation analysis of SIRI and SII with scales and laboratory findings	SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count.	Baseline