Biomarkers in Ankylosing Spondylitis

NCT ID: NCT07117344

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Control

Participants will be seen at one time and serum PGRN and TNF levels will be measured from each of them by ELISA method.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bilimsel Araştirma Projeleri Birimi, Istanbul Üniversitesi

UNKNOWN

Sponsor Role collaborator

Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Seyda Sultan Eraslan

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kırşehir Ahi Evran University

Kırşehir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Şeyda Sultan ERASLAN, MD

Role: CONTACT

+905437676228

Nazife Kapan, Asst. Prof.

Role: CONTACT

+905555839701

Facility Contacts

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Şeyda Sultan ERASLAN, MD

Role: primary

+905437676228

Nazife KAPAN, Asst.Prof.

Role: backup

+90555839701

Other Identifiers

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AhiEvranU-FTR-ŞSE-01

Identifier Type: -

Identifier Source: org_study_id

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