Guselkumab vs Golimumab for Psoriatic Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments, guselkumab and golimumab, to determine which is more effective for people with psoriatic arthritis (PsA) who haven't responded to their current TNFi (a medication that blocks a protein causing inflammation). Researchers aim to discover if switching to guselkumab, which targets a specific immune system protein, is more effective than trying another TNFi like golimumab. This study suits individuals with active PsA symptoms, such as swollen joints or psoriasis plaques, who have previously tried a TNFi without success. Participants will maintain their existing medications at stable doses during the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that guselkumab is safe and effective for people with psoriatic arthritis (PsA). Studies have found it has few side effects, mostly mild ones like common colds. The FDA has already approved guselkumab for PsA, supporting its safety profile.
For golimumab, studies have collected five years of safety data in people with PsA and rheumatoid arthritis. The results showed it helps improve symptoms with manageable side effects. The most common issues are mild and similar to those seen with other treatments in its category.
Both treatments have been used in people with PsA and show promising safety results. For those considering joining a trial, this data suggests these treatments are generally well-tolerated.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for psoriatic arthritis because they offer innovative approaches compared to existing options. Guselkumab is unique as it targets the interleukin-23 (IL-23) pathway, which plays a crucial role in inflammation, potentially offering a more precise way to manage symptoms. On the other hand, Golimumab is a well-known TNF-alpha inhibitor, but its combination with a placebo in this study may provide insights into optimizing its use or identifying patient subgroups that respond best to treatment. These approaches reflect an ongoing effort to tailor treatments more precisely to the underlying mechanisms of psoriatic arthritis.
What evidence suggests that this trial's treatments could be effective for psoriatic arthritis?
This trial will compare the effectiveness of guselkumab and golimumab for treating psoriatic arthritis (PsA). Research has shown that guselkumab, which participants in this trial may receive, holds promise for treating PsA. Studies have found it can greatly reduce the symptoms of active PsA and help prevent joint damage. Specifically, after 24 weeks, patients noticed improvements in their joint health.
Similarly, golimumab, another treatment option in this trial, has proven effective in treating PsA. One study found that 75.1% of patients experienced a 20% improvement in arthritis symptoms by week 14, compared to just 21.8% in those who received a placebo. Both treatments offer significant benefits, but their effectiveness can vary from person to person.16789Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either guselkumab or golimumab, with placebo, to assess effectiveness in PsA patients with inadequate TNFi response
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Golimumab
- Guselkumab
Golimumab is already approved in European Union, United States, Canada for the following indications:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Janssen Scientific Affairs, LLC
Industry Sponsor
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
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University