150 Participants Needed

Guselkumab vs Golimumab for Psoriatic Arthritis

(EVOLUTION Trial)

Recruiting at 13 trial locations
KB
SC
SG
JW
Overseen ByJessica Walsh, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Pennsylvania
Must be taking: TNFi, OSM/csDMARDs
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

Trial Summary

What is the purpose of this trial?

The trial is an open-label randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of any oral small molecule drugs, NSAIDs, glucocorticoids (less than 10 mg daily), or topical medications for psoriasis that you are currently using. You must have been on this stable dose for at least 4 weeks before starting the trial and continue it during the study.

What data supports the effectiveness of the drugs Guselkumab and Golimumab for treating psoriatic arthritis?

Research shows that Golimumab is effective for psoriatic arthritis, especially for patients who did not respond to other similar treatments. Guselkumab has also shown positive results in improving symptoms in psoriatic arthritis and has been effective in treating plaque psoriasis, which is related to psoriatic arthritis.12345

Is Guselkumab or Golimumab safe for humans?

Golimumab has been studied for safety in conditions like rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, with data suggesting it is generally safe for human use. However, specific safety data for Guselkumab in this context is not provided in the available research.26789

How does the drug Guselkumab differ from other treatments for psoriatic arthritis?

Guselkumab is unique because it specifically targets the interleukin-23 (IL-23) pathway, which is different from many other treatments that target tumor necrosis factor (TNF). This makes it a novel option for patients who do not respond well to TNF inhibitors.310111213

Research Team

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

Alexis Ogdie-Beatty, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults aged 18-80 with active psoriatic arthritis who have not responded well to TNF inhibitors. Participants must have at least one active psoriasis plaque and meet specific criteria for joint swelling or tenderness. They should be on a stable dose of certain medications if used, but cannot be pregnant, trying to conceive, or have had serious reactions to similar drugs.

Inclusion Criteria

I am on a stable dose of one specific oral medication for my condition.
I have at least one active psoriasis plaque.
I have been diagnosed with psoriatic arthritis according to CASPAR criteria.
See 4 more

Exclusion Criteria

I have previously been treated with golimumab or similar medications.
I am taking more than 10 mg of steroids daily.
Currently pregnant or actively trying to conceive
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either guselkumab or golimumab based on randomization to assess effectiveness in PsA patients with inadequate response to TNFi

12 months
Visits every 4 or 8 weeks depending on treatment group

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Golimumab
  • Guselkumab
  • Placebo
Trial OverviewThe study compares the effectiveness of two treatments in patients with PsA who haven't done well on TNF inhibitors: Guselkumab (an IL23 inhibitor) versus Golimumab (a second TNFi). It's a randomized double-blind trial where participants won't know which treatment they're getting.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Guselkumab 100mg q8wExperimental Treatment1 Intervention
Guselkumab (GUS) 100mg every 8 weeks
Group II: Guselkumab 100mg q4wExperimental Treatment1 Intervention
Guselkumab (GUS) 100mg every 4 weeks
Group III: Golimumab 50mg q4wActive Control1 Intervention
Golimumab (GOL) 50mg every 4 weeks

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

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+
Ricardo Attar profile image

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis profile image

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD

Findings from Research

In a pooled analysis of 712 patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA), second-line treatment with golimumab (GLM) achieved low disease activity in 58.3% of RA patients and around 45% in PsA and axSpA patients after 6 months, indicating its effectiveness as a treatment option.
The treatment was well-tolerated, with a 12-month persistence rate of 67.8% and no new safety concerns reported, suggesting that GLM is a safe and viable second-line therapy for patients who did not respond to first-line TNFα inhibitors.
Real-world effectiveness of golimumab in the treatment of patients with active rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who failed initial TNF-α inhibitor therapy: a pooled analysis of European prospective observational studie.Govoni, M., Batalov, A., Boumpas, DT., et al.[2023]
In a study of 410 patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), golimumab demonstrated a two-year retention rate of 47.3% for RA, 48% for PsA, and 62.8% for AS, indicating better long-term use in AS patients.
Patients with RA who received golimumab alongside conventional synthetic disease-modifying antirheumatic drugs (sDMARDs) had a lower discontinuation rate compared to those on golimumab alone, suggesting that combination therapy may enhance treatment retention.
Two-year retention rate of golimumab in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: data from the LORHEN registry.Manara, M., Caporali, R., Favalli, EG., et al.[2017]
Guselkumab is an effective treatment for moderate to severe plaque psoriasis, showing superior results compared to placebo and adalimumab in the VOYAGE trials, with benefits maintained for up to 2 years.
Patients who previously did not respond well to ustekinumab showed significantly better outcomes when switched to guselkumab, indicating its efficacy in treatment-resistant cases, while also improving overall quality of life and being well tolerated.
Guselkumab: A Review in Moderate to Severe Plaque Psoriasis.Al-Salama, ZT., Scott, LJ.[2019]

References

Real-world effectiveness of golimumab in the treatment of patients with active rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who failed initial TNF-α inhibitor therapy: a pooled analysis of European prospective observational studie. [2023]
Two-year retention rate of golimumab in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: data from the LORHEN registry. [2017]
Guselkumab: A Review in Moderate to Severe Plaque Psoriasis. [2019]
Golimumab as the First-, Second-, or at Least Third-Line Biologic Agent in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis: Post Hoc Analysis of a Noninterventional Study in Germany. [2021]
Efficacy of Guselkumab on Axial-Related Symptoms Through up to 2 Years in Adults with Active Psoriatic Arthritis in the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Study. [2023]
Comparative Risk of Harm Associated With the Use of Targeted Immunomodulators: A Systematic Review. [2022]
Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab: nationwide observational study emulating a randomised clinical trial. [2021]
The Non-medical Switch from Reference Adalimumab to Biosimilar Adalimumab is Highly Successful in a Large Cohort of Patients with Stable Inflammatory Rheumatic Joint Diseases: A Real-Life Observational Study. [2022]
Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis. [2023]
Guselkumab: First Global Approval. [2019]
Effect of guselkumab on serum biomarkers in patients with active psoriatic arthritis and inadequate response to tumor necrosis factor inhibitors: results from the COSMOS phase 3b study. [2023]
Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. [2020]
Guselkumab for the treatment of adults with moderate to severe plaque psoriasis. [2020]