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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

Study Summary

This trial is testing if a new drug is better than an existing one for treating PsA in people who aren't responding to the existing drug.

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.Check my eligibility

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.See study design

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 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 psoriatic arthritis with swelling or pain in my joints.

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I have been diagnosed with psoriatic arthritis according to CASPAR criteria.

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I am between 18 and 80 years old.

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I have at least one active psoriasis plaque.

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

IGA Psoriasis

cDAPSA

Secondary outcome measures

DLQI

HAQ-DI

PSAID-12

Side effects data

From 2016 Phase 4 trial • 205 Patients • NCT02092285

14%

COLITIS ULCERATIVE

10%

NASOPHARYNGITIS

HEADACHE

OROPHARYNGEAL PAIN

COLITIS

NAUSEA

PULMONARY EMBOLISM

ACCIDENTAL OVERDOSE

100%

80%

60%

40%

20%

Study treatment Arm

Golimumab

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,879,788 Total Patients Enrolled

9 Trials studying Psoriatic Arthritis

3,129 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

Golimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05631457 — Phase 3

Psoriatic Arthritis Research Study Groups: GUS and placebo (4 Weeks), GOL and Placebo, GUS and placebo (8 Weeks)

Psoriatic Arthritis Clinical Trial 2023: Golimumab Highlights & Side Effects. Trial Name: NCT05631457 — Phase 3

Golimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05631457 — 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 dangers are associated with a four-week GUS regimen?

"Our risk assessment of GUS (4 Weeks) gave it a score of 3, as there was ample evidence to support its efficacy and multiple trials proving the drug's safety."

Answered by AI

Does this investigation include senior citizens among its participants?

"This particular trial is available to adult patients between 18 and 80 years of age. It should be noted that there are 53 additional clinical trials catered towards minors, while 322 studies focus on senior citizens."

Answered by AI

What kind of patients would be the most suitable for this clinical experiment?

"This medical investigation aims to enrol 300 individuals with psoriatic arthritis ranging from 18-80 years old. To qualify, the patient must meet certain standards including: having PsA per CASPAR criteria; demonstrating either 2 swollen joints or 1 joint and active enthesitis/dactylitis involving two joints; at least one visible plaque of psoriasis; using a TNFi (with history of TNF IR) or single oral small molecule/csDMARD for four weeks prior to study enrollment and remaining on that same dose during trial duration; max 10 mg daily glucocorticoids if applicable as well as stable NSAID use"

Answered by AI

Is enrollment still available for participants in this examination?

"Per the information posted on clinicaltrials.gov, this scientific trial is no longer actively recruiting participants. It was first proposed on March 1st 2023 and modified lastly on November 18th 2022. Despite that, there are 374 other trials right now admitting patients into their studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)

2023. "Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05631457.

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