Psoriatic Arthritis study: Guselkumab
Official title Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy
ClinicalTrials.gov ID: NCT06586281
What this study is testing
What is Guselkumab?
an investigational injectable medicine being studied as a potential treatment for psoriatic arthritis and related liver disorders is designed to block the activity of interleukin‑23 (IL‑23) in the immune system
Also referred to as Tremfya.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how a biological therapy called guselkumab affects liver problems, joint pain, and skin symptoms in people with psoriatic arthritis and fatty liver disease.
- Who it's for
- People with psoriatic arthritis who also have nonalcoholic fatty liver disease and active joint or skin symptoms.
- What's involved
- Participants will receive guselkumab and have two study visits where doctors check their liver health, joints, and skin.
- Time commitment
- Two visits, timing not specified.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Adults with diagnosis of PsA fulfilling the classification for PsA (CASPAR) criteria.
- 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\.
You likely can't join if
- Patients with prior exposure to IL12/23i, IL-17i, JAKi, or TYK2i. Patients with exposure to more than 2 TNFi.
- 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...
- Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver...
See the full eligibility criteria
- Adults with diagnosis of PsA fulfilling the classification for PsA (CASPAR) criteria.
- 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\.
- Patients with prior exposure to IL12/23i, IL-17i, JAKi, or TYK2i. Patients with exposure to more than 2 TNFi.
- 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...
- 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
- History of known HIV infection
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.