Guselkumab vs Golimumab for Psoriatic Arthritis

Recruiting in Palo Alto (17 mi)

Overseen byAlexis Ogdie-Beatty, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I have psoriatic arthritis with swelling or pain in my joints.

I am on a stable dose of one specific oral medication for my condition.

I have been on a stable dose of NSAIDs, glucocorticoids (less than 10 mg daily), or topical psoriasis medications for 4 weeks.

See 4 more

Exclusion Criteria

I had a bad reaction or cannot take TNFi drugs due to health risks.

I have previously been treated with golimumab or similar medications.

I am taking more than 10 mg of steroids daily.

See 2 more

Treatment Details

Interventions

Golimumab (Monoclonal Antibodies)
Guselkumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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

Golimumab is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Simponi for: