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Clinical Trials in Turkey / NCT06918886
Starting soon Observational

Comparison of Liver Health in Psoriatic Arthritis Patients Using Anti-TNF or Anti-IL17 Treatments

NCT06918886 · tracked via the Priya Life Science Turkey tracker
Sponsor
Bezmialem Vakif University
Phase
Observational
Started
2025-04-10
Last updated
2025-04-09

Condition(s) studied

Psoriatic Arthritis (PsA)Liver FibrosisLiver Diseases

Study summary

Psoriatic arthritis (PsA) is an inflammatory joint disease that can also affect the liver. Some medications used to treat PsA, such as biological agents (TNF-alpha inhibitors and IL-17 inhibitors), may influence liver health over the long term. This retrospective study aims to evaluate the presence and progression of liver fibrosis (scarring) and hepatic steatosis (fatty liver) in PsA patients treated with TNF-alpha inhibitors or IL-17 inhibitors.

The study includes PsA patients who have used biological medications continuously for at least 2 years. Patients' liver health will be assessed using non-invasive tests such as liver ultrasonography and validated biochemical scoring systems (FIB-4, APRI). The findings will be compared with PsA patients treated only with methotrexate (MTX), a commonly used medication known to affect liver health.

This study will help understand whether biological therapies (TNF or IL-17 inhibitors) have a positive or negative impact on liver health compared to traditional treatments (MTX) in patients with psoriatic arthritis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Age 18 to 65 years * Diagnosed with psoriatic arthritis (PsA) according to standard classification criteria * Receiving biologic therapy (anti-TNF or anti-IL-17) or MTX monotherapy for ≥2 years * Able to provide historical data (medical records) on liver ultrasound and laboratory parameters Exclusion Criteria: * History of any other chronic liver disease (e.g., viral hepatitis, autoimmune hepatitis) * Significant alcohol consumption (\>20 g/day women, \>30 g/day men) * Concomitant use of other hepatotoxic drugs apart from MTX * Unwillingness or inability to comply with study assessments

Primary outcome measure(s)

  • Comparison of Liver Health using Fibrosis-4 (FIB-4) Index Score — Outcome assessment at 24 months post-treatment initiation
    The Fibrosis-4 (FIB-4) Index is a tool used for the noninvasive assessment of liver fibrosis. Comparison of liver fibrosis scores (FIB-4) calculated from AST, ALT, platelet counts, and age between Anti-TNF and Anti-IL17 treated Psoriatic Arthritis patients. There is no fixed minimum or maximum value; however, the following threshold values are commonly used in clinical interpretation: \<1.3: Low likelihood of advanced fibrosis 1.3-2.67: Indeterminate/intermediate risk \>2.67: High likelihood of advanced fibrosis. Higher FIB-4 scores indicate the presence of more advanced liver fibrosis.

Trial sites (1)

FacilityCityRegionStatus
Bezmialem Vakif University Istanbul Fatih

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Other trials for the same condition

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis Recruiting
Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06918886 on ClinicalTrials.gov ↗ ← All trials in Turkey