CALLY Index and Disease Activity in Ankylosing Spondylitis

April 3, 2026 updated by: Taner Dandinoğlu, Bursa City Hospital

The CALLY Index May Reflect Systemic Inflammatory Burden Rather Than Patient-Reported Disease Activity in Ankylosing Spondylitis: A Retrospective Cross-Sectional Study

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

Study Overview

Status

Completed

Conditions

Detailed Description

Ankylosing spondylitis is a chronic inflammatory disease in which assessment of disease activity may require both clinical and laboratory-based measures. This retrospective cross-sectional observational study was conducted at Bursa City Hospital, Türkiye, to investigate the relationship between the C-reactive protein-albumin-lymphocyte (CALLY) index and disease-related parameters in patients with ankylosing spondylitis.

Medical records of patients aged 18 years and older who met the modified New York criteria for ankylosing spondylitis and were followed between January 1, 2022, and December 31, 2025, were retrospectively reviewed. Patients with active or chronic infection, malignancy, advanced hepatic or renal disease, nephrotic syndrome, or incomplete data were excluded.

Demographic, clinical, and laboratory data were obtained from medical records. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score based on erythrocyte sedimentation rate (ASDAS-ESR). Functional status was evaluated using the Bath Ankylosing Spondylitis Functional Index (BASFI). The CALLY index was calculated using serum C-reactive protein, albumin, and lymphocyte count values.

The primary objective of the study is to determine whether the CALLY index is associated with disease activity and functional status in ankylosing spondylitis. The study also aims to explore whether this composite biomarker reflects systemic inflammatory burden beyond subjective patient-reported measures. Ethical approval was obtained from the Bursa City Hospital Clinical Research Ethics Committee.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Türkiye
      • Bursa, Türkiye, Turkey (Türkiye), 16600
        • Bursa City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BASDAI and ASDAS-ESR scores in relation to CALLY index
Time Frame: At a single assessment time point
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of CALLY index with BASFI score in patients with ankylosing spondylitis
Time Frame: At a single assessment time point
Assessment of the relationship between the C-reactive protein-albumin-lymphocyte (CALLY) index and functional status as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) 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
Time Frame: At a single assessment time point
Assessment of the association between the CALLY index and laboratory inflammatory markers (CRP, ESR, lymphocyte count, and albumin) in patients with ankylosing spondylitis.
At a single assessment time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

March 29, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-Rheumatology-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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