300 Participants Needed

Guselkumab vs Golimumab for Psoriatic Arthritis

SC
KB
Overseen ByKathleen Bush
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Pennsylvania
Must be taking: TNFi
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Alexis R. Ogdie, MD, MSCE profile ...

Alexis Ogdie-Beatty, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 3 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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: GUS and placebo (8 Weeks)Experimental Treatment1 Intervention
Group II: GUS and placebo (4 Weeks)Experimental Treatment1 Intervention
Group III: GOL and PlaceboActive Control1 Intervention

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

🇪🇺
Approved in European Union as Simponi for:
🇺🇸
Approved in United States as Simponi for:
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Approved in Canada as Simponi for:

Find a Clinic Near You

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+
Joaquin Duato profile image

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

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