NCT07509463

Brief Summary

This retrospective cross-sectional observational study aims to evaluate the association between the C-reactive protein-albumin-lymphocyte (CALLY) index and disease activity and functional status in patients with ankylosing spondylitis. Medical records of adult patients followed between January 1, 2022, and December 31, 2025, were reviewed. Disease activity was assessed using BASDAI and ASDAS-ESR, and functional status was evaluated using BASFI. The study investigates whether the CALLY index reflects systemic inflammatory burden beyond patient-reported disease activity

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 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

January 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

March 29, 2026

Last Update Submit

April 3, 2026

Conditions

Keywords

CALLY indexsystemic inflammationdisease activityBASDAIankylosing spondylitis

Outcome Measures

Primary Outcomes (1)

  • BASDAI and ASDAS-ESR scores in relation to CALLY index

    Assessment of the relationship between the C-reactive protein-albumin-lymphocyte (CALLY) index and disease activity measures, including BASDAI and ASDAS-ESR, in patients with ankylosing spondylitis.

    At a single assessment time point

Secondary Outcomes (2)

  • Correlation of CALLY index with BASFI score in patients with ankylosing spondylitis

    At a single assessment time point

  • Correlation of CALLY index with CRP, ESR, lymphocyte count, and albumin levels in patients with ankylosing spondylitis

    At a single assessment time point

Study Arms (1)

Patients with ankylosing spondylitis

Patients aged 18 years and older with ankylosing spondylitis diagnosed according to the modified New York criteria, whose medical records were retrospectively reviewed between January 1, 2022, and December 31, 2025.

Eligibility Criteria

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

Adult patients with ankylosing spondylitis who were followed at Bursa City Hospital, Türkiye, and whose medical records were retrospectively reviewed between January 1, 2022, and December 31, 2025.

You may qualify if:

  • Age 18 years and older
  • Diagnosis of ankylosing spondylitis according to the modified New York criteria
  • Availability of complete clinical and laboratory data at a single assessment time point

You may not qualify if:

  • Active or chronic infection
  • Malignancy
  • Advanced hepatic or renal disease
  • Having conditions affecting serum albumin levels, such as nephrotic syndrome
  • Incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Türkiye, 16600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2026

First Posted

April 3, 2026

Study Start

January 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations