Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT05669833

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Led by University of Pennsylvania · Updated on 2025-10-09

63

Participants Needed

14

Research Sites

167 weeks

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

J

Janssen Scientific Affairs, LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

The trial is an open-label randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi.

CONDITIONS

Official Title

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of psoriatic arthritis meeting CASPAR criteria
  • Active psoriatic arthritis with at least one swollen joint
  • Clinical Disease Activity index for Psoriatic Arthritis (cDAPSA) score of 10 or higher; for patients without psoriasis, cDAPSA must be above 14
  • Currently using or previously used one TNFi and planning to switch due to inadequate response
  • Stable dose of up to two oral small molecule or conventional synthetic DMARDs for at least 4 weeks prior to study start
  • Stable dose of NSAIDs, glucocorticoids under 10 mg daily, or topical psoriasis medications for at least 4 weeks prior to screening
  • Age between 18 and 80 years
Not Eligible

You will not qualify if you...

  • Prior use of golimumab or any non-TNFi biologic (IL12/23 inhibitors, JAK inhibitors, IL17 inhibitors, or IL23 inhibitors)
  • History of adverse events preventing use of TNFi, including drug-induced lupus, allergic reactions, serious infections, heart failure symptoms, or demyelination
  • Use of moderate to high doses of glucocorticoids over 10 mg daily
  • Already meeting low disease activity criteria at baseline (cDAPSA 14 or less with low psoriasis activity)
  • Currently pregnant or actively trying to conceive

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Family Arthritis Center

Loxahatchee Groves, Florida, United States, 33470

Actively Recruiting

2

Healing Rheumatology

Plant City, Florida, United States, 33563

Actively Recruiting

3

Southwest Florida Rheumatology

Riverview, Florida, United States, 33569

Actively Recruiting

4

Parris and Associates

Lilburn, Georgia, United States, 30047

Actively Recruiting

5

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States, 01655

Actively Recruiting

6

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

7

New York University

New York, New York, United States, 10016

Actively Recruiting

8

Cincy Arthritis

Blue Ash, Ohio, United States, 45242

Actively Recruiting

9

Southern Ohio Rheumatology

Wheelersburg, Ohio, United States, 45694

Actively Recruiting

10

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

11

Cumberland Rheumatology

Crossville, Tennessee, United States, 38555

Actively Recruiting

12

Heritage Rheumatology and Arthritis Care

Colleyville, Texas, United States, 76034

Actively Recruiting

13

Texas Arthritis Center

El Paso, Texas, United States, 79902

Actively Recruiting

14

University of Utah

Salt Lake City, Utah, United States, 84132

Actively Recruiting

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Research Team

S

Sarah Gillespie

CONTACT

S

Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients | DecenTrialz