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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

EVOLUTION 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.Check my eligibility

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.See study design

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.

EVOLUTION Trial 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.

EVOLUTION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Achievement of cDAPSA low disease activity

Investigator Global Assessment of Psoriasis of Clear or Almost Clear

Secondary outcome measures

Change in BASDAI

Change in DLQI

Change in PSAID-12

+8 more

EVOLUTION Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: GUS and PlaceboExperimental Treatment2 Interventions

Guselkumab (GUS) and Matching Placebo

Group II: GUSExperimental Treatment1 Intervention

Guselkumab (GUS)

Group III: GOLActive Control1 Intervention

Golimumab (GOL)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Guselkumab

2015

Completed Phase 4

~5990

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,881,987 Total Patients Enrolled

9 Trials studying Psoriatic Arthritis

3,129 Patients Enrolled for Psoriatic Arthritis

Janssen Scientific Affairs, LLCIndustry Sponsor

159 Previous Clinical Trials

580,218 Total Patients Enrolled

2 Trials studying Psoriatic Arthritis

700 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: GOL, GUS, GUS and Placebo

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks could be associated with utilization of GUS in patients?

"Data collected from previous phases of the study has established a solid foundation for GUS's safety, thus granting it an overall score of 3."

Answered by AI

Does this research opportunity extend to elderly participants?

"This research requires that participants fall between the age ranges of 18 to 80. Additionally, there are 52 clinical trials specifically designed for individuals younger than eighteen and 320 trials tailored for those above 65 years old."

Answered by AI

Are researchers actively seeking participants for this experiment?

"According to clinicaltrials.gov, this specific study is not currently recruiting patients for participation. Initially posted on February 1st 2023 and last updated on December 20th 2022, the trial has yet to begin its search for participants; however, there are 370 other trials actively looking for volunteers at present."

Answered by AI

Does my profile satisfy the criteria for inclusion in this clinical trial?

"This medical trial has 300 openings for those with psoriatic arthritis, aged 18-80. Crucially, to be considered interested parties must fit the following criteria: meeting CASPAR; having two swollen joints/enthesitis OR one active dactylitis involving two joints and at least one plaque of psoriasis; using or previously used a TNFi but did not respond (TNF IR) and planning on switching biologic therapies; if taking single oral small molecules/csDMARDs such as methotrexate, leflunomide, hydroxychloroquine, sulfasalazine or apremilast"

Answered by AI

What does this clinical investigation aim to uncover?

"The primary evaluation of this trial, conducted over a 12 month period, is based on the Investigator Global Assessment of Psoriasis; aiming to achieve Clear or Almost Clear results. Secondary measures include Minimal Disease Activity (MDA) assessed with HAQ-DI which requires 5/7 criteria be met including Patient Global ≤ 2 (0-10), patient pain ≤ 2 (0-10), HAQ-DI < 0.5 (0-3), TJC ≤ 1, SJC ≤1 BSA≤ 3 and Leeds Enthesitis Index ≤ 1 as well as Change in PSAID-12 Survey from baseline values"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

2023. "Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05669833.

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