NCT07117344

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

August 5, 2025

Last Update Submit

January 16, 2026

Conditions

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

Keywords

ankylosing spondylitistnfProgranulindisease activity

Outcome Measures

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.

    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.

    Patient will be seen only once

Secondary Outcomes (5)

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Patient will be seen only once

  • Ankylosing Spondylitis Disease Activity Scoring-CRP (ASDAS-CRP)

    Patient will be seen only once

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    Patient will be seen only once

  • Bath Ankylosing Spondylitis Metrology Index (BASMI)

    Patient will be seen only once

  • Ankylosing Spondylitis Quality of Life Scale (ASQoL)

    Patient will be seen only once

Study Arms (3)

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.

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Between the ages of 20-65
  • Signing the informed consent form
  • Axial spondyloarthropathy diagnosis according to ASAS 2009 criteria

You may not qualify if:

  • Pregnancy or lactation
  • Having signs of acute or chronic infection
  • Presence of malignancy
  • Having concurrent secondary rheumatic disease other than Axial Spondyloarthropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples taken from the patient will be centrifuged and stored as serum

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Central Study Contacts

Şeyda Sultan ERASLAN, MD

CONTACT

+905437676228sultaneraslan353@gmail.com

Nazife Kapan, Asst. Prof.

CONTACT

+905555839701

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

January 15, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)