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Monoclonal Antibodies

Guselkumab for Psoriatic Arthritis

N/A
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have 1 or more swollen joint(s) and/or one or more active sites of enthesitis AND/OR 1 or more psoriatic plaques
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
Must not have
Patients with prior exposure to IL12/23i, IL-17i, JAKi, or TYK2i. Patients with exposure to more than 2 TNFi
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Summary

This trial aims to understand how Nonalcoholic fatty liver disease (NAFLD) progresses to high-risk nonalcoholic steatohepatitis (NASH) in patients with Psoriatic Ar

Who is the study for?
This trial is for patients with Psoriatic Arthritis (PsA) who also have Nonalcoholic fatty liver disease (NAFLD). Participants should show active signs of PsA, like swollen joints or skin plaques. Specific eligibility criteria are not provided, but typically include factors like age, overall health, and the severity of conditions.
What is being tested?
The study tests Guselkumab therapy's effects on NAFLD and PsA severity. It involves two visits from participants to assess how this biological therapy impacts liver health as well as joint and skin symptoms associated with PsA.
What are the potential side effects?
While specific side effects for Guselkumab in this trial context aren't detailed here, common ones may include injection site reactions, headaches, upper respiratory infections, fatigue, and potential serious allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have swollen joints, active enthesitis, or psoriatic plaques.
Select...
My regular medications have been the same for the last 3 months and I haven't taken steroids in the last 8 weeks.
Select...
My liver tests show I have fatty liver disease not caused by other liver conditions.
Select...
I have been diagnosed with Psoriatic Arthritis according to CASPAR criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been treated with specific immune-targeting drugs or more than 2 TNF blockers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in NAFLD severity
Secondary study objectives
Change from baseline in skin psoriasis severity
Change in ALT Levels
Change in joint arthritis

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
1%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Ixekizumab
Guselkumab
Guselkumab Post-Treatment Follow Up

Trial Design

1Treatment groups
Experimental Treatment
Group I: psoriatic arthritis patientsExperimental Treatment1 Intervention
Adults with active PsA and diagnosed NAFLD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~6080

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,166 Previous Clinical Trials
1,569,251 Total Patients Enrolled
3 Trials studying Psoriatic Arthritis
1,358 Patients Enrolled for Psoriatic Arthritis
Janssen Scientific Affairs, LLCIndustry Sponsor
163 Previous Clinical Trials
579,943 Total Patients Enrolled
3 Trials studying Psoriatic Arthritis
850 Patients Enrolled for Psoriatic Arthritis
~13 spots leftby Sep 2026
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