Guselkumab vs Golimumab for Psoriatic Arthritis

Overseen By Kathleen Bush

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Pennsylvania

Must be taking: TNFi

Must not be taking: Golimumab, IL12/23i, JAKi, IL17i

Disqualifiers: Pregnancy, Heart failure, Serious infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

300 Participants Needed

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.

Research Team

Alexis Ogdie-Beatty, MD

Principal Investigator

University of Pennsylvania

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either guselkumab or golimumab, with placebo, to assess effectiveness in PsA patients with inadequate TNFi response

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Golimumab
• Guselkumab

Trial Overview 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.

Participant Groups

Group I: GUS and placebo (8 Weeks) Experimental Treatment 1 Intervention

Guselkumab (GUS) and placebo (8 Weeks)

Group II: GUS and placebo (4 Weeks) Experimental Treatment 1 Intervention

Guselkumab (GUS) and placebo (4 Weeks)

Group III: GOL and Placebo Active Control 1 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:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Ulcerative colitis

Approved in United States as Simponi for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Ulcerative colitis

Approved in Canada as Simponi for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Ulcerative colitis

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD