Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA)NCT07117344
Biomarkers in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA), run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to compare serum PGRN(progranulin) and TNF-α levels in AS patients with healthy controls and to determine the relationship between TNF-α inhibitor use and PGRN levels in AS patients. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA)
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 30 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inclusion Criteria: * Between the ages of 20-65 * Signing the informed consent form * Axial spondyloarthropathy diagnosis according to ASAS 2009 criteria Exclusion Criteria: * Pregnancy or lactation * Having signs of acute or chronic infection * Presence of malignancy * Having concurrent secondary rheumatic disease other than Axial Spondyloarthropathy The healthy control group Inclusion Criteria: * Between the ages of 20-65 * Signing the informed consent form Exclusion Criteria: Exclusion Criteria: * Pregnancy or lactation * Having signs of acute or chronic infection * Presence of malignancy or rheumatic diseases.
Who may be able to join
- Between the ages of 20-65
- Signing the informed consent form
- Axial spondyloarthropathy diagnosis according to ASAS 2009 criteria
Who cannot join
- Pregnancy or lactation
- Having signs of acute or chronic infection
- Presence of malignancy
- Having concurrent secondary rheumatic disease other than Axial Spondyloarthropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Progranulin in Ankylosing Spondylitis Patients: A Potential Biomarker?"
In this study, we aimed to compare serum PGRN(progranulin) and TNF-α levels in AS patients with healthy controls and to determine the relationship between TNF-α inhibitor use and PGRN levels in AS patients.
Read the detailed description
Axial Spondyloarthritis is a heterogeneous group of diseases characterised by inflammatory low back pain, sacroiliitis, asymmetric oligoarthritis, dactylitis, enthesitis and uveitis.
The fact that PGRN acts by binding to TNF-α receptors, the use of TNF-α inhibitors in current treatment in patients with AS and the importance of this pathway in disease pathogenesis suggested that PGRN may be a marker associated with disease activity in these patients. In this study, we aimed to compare serum PGRN and TNF-α levels in patients with AS with healthy control group and to determine the relationship between TNF-α inhibitor use and PGRN levels in patients with AS.
In our study, 80 patients aged 20-65 years who were diagnosed with AS according to ASAS 2009 criteria and followed up in our clinic will be included. Patients with pregnancy or lactation status, acute or chronic infection findings, malignancy, and the presence of concurrent secondary rheumatic diseases other than AS will be excluded. As a healthy control group, 80 people aged 20-65 years without pregnancy or lactation, acute or chronic infection, malignancy and rheumatic disease will be recruited. Age, gender, comorbidities, duration of the disease, and medications used by all patients will be recorded. In addition, BASDAI, BASFI, BASMI, ASQoL, ASDAS-CRP, ESR, CRP levels will be recorded to determine the severity of AS clinically in the patient group. Participants in the patient and control groups will be seen at one time and serum PGRN and TNF levels will be measured by ELISA method.
- Keywords
- ankylosing spondylitis, tnf, Progranulin, disease activity
- 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 on TNF inhibitors | Participants will be seen at one time and serum PGRN and TNF levels will be measured from each of them by ELISA method. | |
| patients with ankylosing spondylitis taking non-steroidal anti-inflammatory drugs | Participants will be seen at one time and serum PGRN and TNF levels will be measured from each of them by ELISA method. | |
| Control | Participants will be seen at one time and serum PGRN and TNF levels will be measured from each of them by ELISA method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In this study, we aimed to compare serum PGRN and TNF-α levels in AS patients with healthy controls and to determine the relationship between TNF-α inhibitor use and PGRN levels in AS patients.
In this study, we aimed to compare serum PGRN and TNF-α levels in AS patients with healthy controls and to determine the relationship between TNF-α inhibitor use and PGRN levels in AS patients.
Measured: Patient will be seen only once
Secondary outcomes (5)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); BASDAI score consists of 6 questions. Patients are asked to give a score between 0 and 10 to each question as 'none' 0 points, 'very severe' 10 points according to their symptoms 1 week ago. Afterwards, the scores of the 5th and 6th questions are summed among themselves, divided by 2, added to the other scores and divided by 5 in total to obtain the BASDAI score. A BASDAI score of 4 and above indicates that the disease is out of control and that the patient's treatment, especially biological agents, should be reviewed. In the evaluation of response to treatment, a 50% improvement in the BASDAI score or a regression of at least 2 units on a 10-point scale is required
Translated with DeepL.com (free version)
Measured: Patient will be seen only once
Ankylosing Spondylitis Disease Activity Scoring-CRP (ASDAS-CRP)
Ankylosing Spondylitis Disease Activity Scoring-CRP (ASDAS-CRP) is a combined scoring system that measures disease activity. It is calculated by adding CRP value to clinical findings. According to the score obtained, disease activity is grouped as inactive, low, high and very high. In order to be considered for initiation of biological treatment, the ASDAS score must be at least 2.1. A change of 1.1 and above in the ASDAS score is considered a significant improvement, while changes of 2.0 and above are considered major improvements. For exacerbation in disease activity, there should be a change of 0.9 and above in the ASDAS score
Measured: Patient will be seen only once
Bath Ankylosing Spondylitis Functional Index (BASFI)
Bath Ankylosing Spondylitis Functional Index (BASFI); patients are asked a total of 10 questions, including functional questions, and asked to score each question between 0 and 10, with 'easy' being 0 points and 'impossible' being 10 points. The score given to each question is summed and divided by 10 and the BASFI score is obtained .
Measured: Patient will be seen only once
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Bath Ankylosing Spondylitis Metrology Index (BASMI); metrological evaluation of patients is performed with this scoring. The score is calculated by measuring lumbar lateral flexion, tragus wall distance, modified schober test, cervical rotation and intermalleolar distance. It is used as a follow-up parameter in spinal mobility measurements
Measured: Patient will be seen only once
Ankylosing Spondylitis Quality of Life Scale (ASQoL)
Ankylosing Spondylitis Quality of Life Scale (ASQoL) consists of 18 questions with a yes answer of 1 point and a no answer of 0 point. The score is calculated by summing the scores given to all questions. An increase in the score indicates poor quality of life
Measured: Patient will be seen only once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Jan 2026
- Primary completion20 May 2026
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA)Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Bilimsel Araştirma Projeleri Birimi, Istanbul Üniversitesi
- Responsible party
- Principal investigator, Seyda Sultan Eraslan, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117344
- Sponsor's protocol ID
- AhiEvranU-FTR-ŞSE-01
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No