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Monoclonal Antibodies

Guselkumab vs Golimumab for Psoriatic Arthritis (EVOLUTION Trial)

Phase 3
Recruiting
Led By Alexis Ogdie-Beatty, MD, MSCE
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
At least one active psoriasis plaque
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
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare two treatments for PsA to see which is more effective at helping those who haven't responded to current treatments.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include injection site reactions, infections due to weakened immune response, allergic reactions, and possibly others depending on individual health conditions. The exact side effects will vary between the two drugs being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on a stable dose of one specific oral medication for my condition.
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I have at least one active psoriasis plaque.
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I have been diagnosed with psoriatic arthritis according to CASPAR criteria.
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I have psoriatic arthritis with swelling or pain in my joints.
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I am between 18 and 80 years old.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with golimumab or similar medications.
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I am taking more than 10 mg of steroids daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Achievement of cDAPSA low disease activity
Investigator Global Assessment of Psoriasis of Clear or Almost Clear
Secondary study objectives
Change in BASDAI
Change in DLQI
Change in PSAID-12
+8 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
1%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Ixekizumab
Guselkumab
Guselkumab Post-Treatment Follow Up

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~6080

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,076 Previous Clinical Trials
42,719,675 Total Patients Enrolled
9 Trials studying Psoriatic Arthritis
3,129 Patients Enrolled for Psoriatic Arthritis
Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
579,823 Total Patients Enrolled
3 Trials studying Psoriatic Arthritis
720 Patients Enrolled for Psoriatic Arthritis
Alexis Ogdie-Beatty, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
161 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
90 Patients Enrolled for Psoriatic Arthritis

Media Library

Golimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05669833 — Phase 3
Psoriatic Arthritis Research Study Groups: Guselkumab 100mg q4w, Guselkumab 100mg q8w, Golimumab 50mg q4w
Psoriatic Arthritis Clinical Trial 2023: Golimumab Highlights & Side Effects. Trial Name: NCT05669833 — Phase 3
Golimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05669833 — Phase 3
~77 spots leftby May 2026
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