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Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy

Elucidating Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Arthritis (PsA) Disease Severity With Guselkumab Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This study involves two visits from PsA patients with NAFLD and active disease signs (e.g., swollen joint, enthesitis, or psoriatic plaque)."
  • "The proposed study aims to explore shared pathogenic pathways in NAFLD and PsA by evaluating the role of IL-17/23 through imaging, metabolomics, and synovial biopsies."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how guselkumab treatment affects the liver, joints, and skin. It is for adults with active psoriatic arthritis (PsA) and nonalcoholic fatty liver disease (NAFLD), a buildup of fat in the liver. The study includes two visits.

While many studies examine Nonalcoholic fatty liver disease (NAFLD), little is known about its progression to high-risk nonalcoholic steatohepatitis (NASH) in PsA patients. Shared disease mechanisms may explain the increased severity in PsA. This study involves two visits from PsA patients with NAFLD and active disease signs (e.g., swollen joint, enthesitis, or psoriatic plaque). It aims to assess the impact of biological therapies on liver disorders, joints, and skin in PsA patients.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult with PsA who meets the study’s diagnosis rules.
  • You have at least one swollen joint, an inflamed spot where a tendon or ligament joins bone, or a raised patch of psoriasis skin.
  • Your regular medicines have not changed in the past 3 months.
  • You have not used steroids that affect the whole body or used steroids long-term in the past 8 weeks.
  • Your body mass index (BMI), a measure based on height and weight, is at least 25, or at least 23 if you are Asian.
  • You are starting guselkumab for PsA as recommended by your arthritis doctor.
  • Your liver fat test (CAP) result is at least 288 dB/m, showing NAFLD after other causes of liver disease are ruled out.

Who can't join

  • You have used medicines called IL-12/23, IL-17, JAK, or TYK2 inhibitors, or more than two TNF inhibitors. These medicines block parts of the immune system.
  • You have another cause of long-term liver disease, such as hepatitis B or C, immune system disease, inherited disease, medicine-related damage, or blocked bile ducts.
  • You have had stomach or bowel bypass surgery, or used medicines known to cause liver fat in the past 6 months.
  • You have cirrhosis, which is severe liver scarring, or signs of it on past tests or in your health history.
  • Within the past 10 years, you drank more than 30 grams of alcohol daily if male, or 15 grams daily if female, for longer than 2 years.
  • Your blood creatinine, a measure of kidney function, is above 2.0 mg/dL.
  • You are pregnant, breastfeeding, or planning to become pregnant.
  • You have a known history of HIV infection, or your expected lifespan is less than 5 years.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Adults with diagnosis of PsA fulfilling the classification for PsA (CASPAR) criteria. 2. Must have: 1 or more swollen joint(s) and/or one or more active sites of enthesitis 3\. AND/OR 1 or more psoriatic plaques 4\. No changes in the regular medication regimen within the last three months, and no use of systemic and/or chronic steroids within 8 weeks leading up to the study. 5\. Overweight or obese by BMI ≥ 25.0 kg/m2 or ≥ 23.0 for Asian participants 6\. Patients are starting Guselkumab therapy for PsA as indicated by primary rheumatologist 7\. Elevated liver fat on controlled attenuation parameter (CAP) ≥ 288 dB/m, which is consistent with NAFLD after exclusion of secondary causes of liver disease. Exclusion Criteria: 1. Patients with prior exposure to IL12/23i, IL-17i, JAKi, or TYK2i. Patients with exposure to more than 2 TNFi. 2. Evidence of other causes of chronic liver disease * Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg). * Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Abin serum (anti-HCV Ab). * Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy. * Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis. * Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease. * Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency. * Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D. * Drug-induced liver disease as defined on the basis of typical exposure and history. * Bile duct obstruction as shown by imaging studies. * History of gastrointestinal bypass surgery or ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, amiodarone or tetracycline in the previous 6 months. * Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices * Presence of regular and/or excessive use of alcohol (defined as \>30g/day for males and \>15g/day for females) for a period longer than 2 years at any times in the last 10 years * Serum creatinine \> 2.0 mg/dL * The subject is a pregnant or nursing female or is planning to become pregnant * Life expectancy less than 5 years 3. History of known HIV infection

Study sites (1)

CA