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NCT Number: NCT07117344

Biomarkers in Ankylosing Spondylitis

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.

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Key information

Conditions

Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA) Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: Patient will be seen only once

    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.

Secondary outcomes

  1. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: Patient will be seen only once

    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)

  2. Ankylosing Spondylitis Disease Activity Scoring-CRP (ASDAS-CRP)

    Time frame: Patient will be seen only once

    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

  3. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: Patient will be seen only once

    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 .

  4. Bath Ankylosing Spondylitis Metrology Index (BASMI)

    Time frame: Patient will be seen only once

    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

  5. Ankylosing Spondylitis Quality of Life Scale (ASQoL)

    Time frame: Patient will be seen only once

    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

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Collaborators

  • Bilimsel Araştirma Projeleri Birimi, Istanbul Üniversitesi

Registry information

Official study title

"Progranulin in Ankylosing Spondylitis Patients: A Potential Biomarker?"

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2025
Registry last updated
Jun 2, 2026

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

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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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