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NCT Number: NCT07509463

CALLY Index and Disease Activity in Ankylosing Spondylitis

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

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Key information

Conditions

Anklyosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa City Hospital

Bursa, Türkiye, 16600, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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