Anklyosing SpondylitisNCT07509463
CALLY Index and Disease Activity in Ankylosing Spondylitis
An observational study of Anklyosing Spondylitis, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anklyosing Spondylitis
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Active or chronic infection
- Malignancy
- Advanced hepatic or renal disease
- Having conditions affecting serum albumin levels, such as nephrotic syndrome
- Incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Anklyosing Spondylitis
- Keywords
- CALLY index, systemic inflammation, disease activity, BASDAI, ankylosing spondylitis
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At a single assessment time point
Secondary outcomes (2)
Correlation of CALLY index with BASFI score in patients with ankylosing spondylitis
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.
Measured: At a single assessment time point
Correlation of CALLY index with CRP, ESR, lymphocyte count, and albumin levels in patients with ankylosing spondylitis
Assessment of the association between the CALLY index and laboratory inflammatory markers (CRP, ESR, lymphocyte count, and albumin) in patients with ankylosing spondylitis.
Measured: At a single assessment time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Jan 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anklyosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Taner Dandinoğlu, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509463
- Sponsor's protocol ID
- 2026-Rheumatology-6
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CALLY Index May Reflect Systemic Inflammatory Burden Rather Than Patient-Reported Disease Activity in Ankylosing Spondylitis: A Retrospective Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07509463
- Acronym / sponsor ID
- 2026-Rheumatology-6
- Conditions
- Anklyosing Spondylitis
- Keywords
- CALLY index, systemic inflammation, disease activity, BASDAI, ankylosing spondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Active or chronic infection
- Malignancy
- Advanced hepatic or renal disease
- Having conditions affecting serum albumin levels, such as nephrotic syndrome
- Incomplete data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Correlation of CALLY index with BASFI score in patients with ankylosing spondylitis
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Anklyosing Spondylitis
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Effectiveness of Telerehabilitation in Ankylosing Spondylitis
Anklyosing Spondylitis, Telerehabilitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anklyosing Spondylitis, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BASDAI and ASDAS-ESR scores in relation to CALLY index (time frame: At a single assessment time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.