Comparison of Liver Health in Psoriatic Arthritis Patients Using Anti-TNF or Anti-IL17 Treatments
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorBezmialem Vakif University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
This study population comprises adult PsA patients (aged 18 to 65) under active follow-up at the Physical Medicine and Rehabilitation Clinic. Eligible participants have confirmed PsA diagnoses and must have been treated either with methotrexate (MTX) alone or with biologic agents (anti-TNF or anti-IL-17) for at least two years. Data from medical records-including liver ultrasound reports, laboratory results, and relevant clinical assessments-will be collected retrospectively. Patients with significant alcohol use or other known causes of chronic liver disease are excluded. The sample is expected to encompass a range of disease severities, allowing for meaningful comparison of liver health outcomes across different therapeutic regimens.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 3 trial groupsGroup A: Group 1: Anti-TNF treatment
Group B: Group 2: Anti-IL17 treatment
Group C: MTX Control Group
Trial outcomes
Primary outcomes
1
Comparison of Liver Health using Fibrosis-4 (FIB-4) Index Score
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.
Time frame
Outcome assessment at 24 months post-treatment initiationSecondary outcomes
1
Identification of High-Risk Patients
Determining the percentage of patients with elevated FIB-4 scores suggestive of liver fibrosis risk in each treatment group (Anti-TNF vs. Anti-IL17).Higher FIB-4 scores indicate the presence of more advanced liver fibrosis.
Time frame
Outcome assessment at 24 months post-treatment initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: