← Back to Search

Monoclonal Antibodies

Guselkumab vs Golimumab for Psoriatic Arthritis

Phase 3
Waitlist Available
Led By Alexis Ogdie-Beatty, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If using a single oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxycloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study. Only use of a single OSM/csDMARD is allowed
Active psoriatic arthritis defined by the presence of at least 2 swollen joints OR 1 swollen joint and 1 site of active enthesitis OR active dactylitis involving 2 joints
Must not have
Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i)
Use of moderate to high dose glucocorticoids (>10 mg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare two medications, guselkumab and golimumab, in patients with psoriatic arthritis who did not respond well to their initial treatment. The goal is to see if switching to guselkumab is more effective than trying another similar medication. Guselkumab is used for treating moderate-to-severe plaque psoriasis in adults and has shown additional benefits in patients who did not respond well to other treatments.

Who is the study for?
This trial is for adults aged 18-80 with active psoriatic arthritis who haven't responded well to their first TNF inhibitor treatment. They must have at least one swollen joint or enthesitis site, be on a stable dose of certain oral medications if used, and not be pregnant or trying to conceive. Those previously treated with golimumab or other non-TNF biologics, or who've had serious side effects from TNF inhibitors can't join.
What is being tested?
The EVOLUTION study is testing whether guselkumab (an IL23 inhibitor) is more effective than golimumab (a second type of TNFi) in patients with PsA who didn’t respond well to an initial TNFi treatment. It's a double-blinded study where participants are randomly assigned to receive either guselkumab or golimumab.
What are the potential side effects?
Potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression, allergic reactions, and possibly others that are common with treatments affecting the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on a stable dose of one specific oral medication for my condition.
Select...
I have psoriatic arthritis with swelling or pain in my joints.
Select...
I have been diagnosed with psoriatic arthritis according to CASPAR criteria.
Select...
I am between 18 and 80 years old.
Select...
I have at least one active psoriasis plaque.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have previously been treated with golimumab or similar medications.
Select...
I am taking more than 10 mg of steroids daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
IGA Psoriasis
cDAPSA
Secondary study objectives
DLQI
HAQ-DI
PSAID-12

Side effects data

From 2016 Phase 4 trial • 205 Patients • NCT02092285
14%
COLITIS ULCERATIVE
10%
NASOPHARYNGITIS
7%
OROPHARYNGEAL PAIN
7%
HEADACHE
7%
COLITIS
7%
NAUSEA
1%
PULMONARY EMBOLISM
1%
ACCIDENTAL OVERDOSE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Golimumab

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: GUS and placebo (8 Weeks)Experimental Treatment1 Intervention
Guselkumab (GUS) and placebo (8 Weeks)
Group II: GUS and placebo (4 Weeks)Experimental Treatment1 Intervention
Guselkumab (GUS) and placebo (4 Weeks)
Group III: GOL and PlaceboActive Control1 Intervention
Golimumab (GOL) and placebo

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Psoriatic Arthritis (PsA) treatments often target specific immune pathways to reduce inflammation and halt disease progression. Guselkumab, a selective IL-23 inhibitor, works by blocking the IL-23 cytokine, which is crucial in the inflammatory process of PsA. This inhibition helps reduce the activity of Th17 cells, which are implicated in the pathogenesis of PsA. Other common treatments include TNF inhibitors like golimumab, which block the tumor necrosis factor (TNF) involved in systemic inflammation. These targeted therapies are essential for PsA patients as they offer more precise control over the immune response, potentially leading to better management of symptoms and slowing of disease progression.

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
579,673 Total Patients Enrolled
3 Trials studying Psoriatic Arthritis
570 Patients Enrolled for Psoriatic Arthritis
University of PennsylvaniaLead Sponsor
2,072 Previous Clinical Trials
42,713,686 Total Patients Enrolled
9 Trials studying Psoriatic Arthritis
2,979 Patients Enrolled for Psoriatic Arthritis
Alexis Ogdie-Beatty, MDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
227 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
187 Patients Enrolled for Psoriatic Arthritis

Media Library

Golimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05631457 — Phase 3
Psoriatic Arthritis Research Study Groups: GUS and placebo (4 Weeks), GOL and Placebo, GUS and placebo (8 Weeks)
Psoriatic Arthritis Clinical Trial 2023: Golimumab Highlights & Side Effects. Trial Name: NCT05631457 — Phase 3
Golimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05631457 — Phase 3
~56 spots leftby May 2025