Actively Recruiting
Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy
Led by University of California, San Diego · Updated on 2025-04-03
20
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
J
Janssen Scientific Affairs, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults diagnosed with psoriatic arthritis meeting CASPAR criteria
- Presence of one or more swollen joints and/or active enthesitis
- Presence of one or more psoriatic plaques
- No changes in regular medications in the last 3 months
- No use of systemic or chronic steroids within 8 weeks before the study
- Overweight or obese with BMI 25.0 kg/m2 or 23.0 kg/m2 for Asian participants
- Starting guselkumab therapy for psoriatic arthritis as prescribed by primary rheumatologist
- Elevated liver fat on controlled attenuation parameter (CAP) 28 dB/m consistent with NAFLD after excluding other liver diseases
You will not qualify if you...
- Prior exposure to IL12/23 inhibitors, IL-17 inhibitors, JAK inhibitors, TYK2 inhibitors, or more than two TNF inhibitors
- Other chronic liver diseases including hepatitis B or C, autoimmune hepatitis, autoimmune cholestatic liver disorders, Wilson disease, alpha-1-antitrypsin deficiency, hemochromatosis, drug-induced liver disease, bile duct obstruction
- History of gastrointestinal bypass surgery or use of medications causing liver fat accumulation in the last 6 months
- Evidence or history of cirrhosis or portal hypertension
- Regular or excessive alcohol use exceeding defined limits for more than 2 years within the last 10 years
- Serum creatinine greater than 2.0 mg/dL
- Pregnant, nursing, or planning pregnancy
- Life expectancy less than 5 years
- Known HIV infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Diego
San Diego, California, United States, 92037
Actively Recruiting
Research Team
M
Mehrnaz Aghili
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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