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Monoclonal Antibodies
Guselkumab vs Golimumab for Psoriatic Arthritis
Phase 3
Waitlist Available
Led By Alexis Ogdie-Beatty, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
If using a single oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxycloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study. Only use of a single OSM/csDMARD is allowed
Active psoriatic arthritis defined by the presence of at least 2 swollen joints OR 1 swollen joint and 1 site of active enthesitis OR active dactylitis involving 2 joints
Must not have
Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i)
Use of moderate to high dose glucocorticoids (>10 mg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
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 the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression, allergic reactions, and possibly others that are common with treatments affecting the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on a stable dose of one specific oral medication for my condition.
Select...
I have psoriatic arthritis with swelling or pain in my joints.
Select...
I have been diagnosed with psoriatic arthritis according to CASPAR criteria.
Select...
I am between 18 and 80 years old.
Select...
I have at least one active psoriasis plaque.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously been treated with golimumab or similar medications.
Select...
I am taking more than 10 mg of steroids daily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
IGA Psoriasis
cDAPSA
Secondary study objectives
DLQI
HAQ-DI
PSAID-12
Side effects data
From 2016 Phase 4 trial • 205 Patients • NCT0209228514%
COLITIS ULCERATIVE
10%
NASOPHARYNGITIS
7%
OROPHARYNGEAL PAIN
7%
HEADACHE
7%
COLITIS
7%
NAUSEA
1%
PULMONARY EMBOLISM
1%
ACCIDENTAL OVERDOSE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Golimumab
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Psoriatic Arthritis (PsA) treatments often target specific immune pathways to reduce inflammation and halt disease progression. Guselkumab, a selective IL-23 inhibitor, works by blocking the IL-23 cytokine, which is crucial in the inflammatory process of PsA.
This inhibition helps reduce the activity of Th17 cells, which are implicated in the pathogenesis of PsA. Other common treatments include TNF inhibitors like golimumab, which block the tumor necrosis factor (TNF) involved in systemic inflammation.
These targeted therapies are essential for PsA patients as they offer more precise control over the immune response, potentially leading to better management of symptoms and slowing of disease progression.
Find a Location
Who is running the clinical trial?
Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
579,673 Total Patients Enrolled
3 Trials studying Psoriatic Arthritis
570 Patients Enrolled for Psoriatic Arthritis
University of PennsylvaniaLead Sponsor
2,072 Previous Clinical Trials
42,713,686 Total Patients Enrolled
9 Trials studying Psoriatic Arthritis
2,979 Patients Enrolled for Psoriatic Arthritis
Alexis Ogdie-Beatty, MDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
227 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
187 Patients Enrolled for Psoriatic Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 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.I have used a TNF inhibitor for my condition without success or it stopped working, and I plan to switch to a new biologic therapy.I am taking more than 10 mg of steroids daily.You have already shown the main result of the study before it even started.I have been diagnosed with psoriatic arthritis according to CASPAR criteria.I am between 18 and 80 years old.I have at least one active psoriasis plaque.
Research Study Groups:
This trial has the following groups:- Group 1: GUS and placebo (4 Weeks)
- Group 2: GOL and Placebo
- Group 3: GUS and placebo (8 Weeks)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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