Recruiting
Phase 3

Guselkumab vs. Golimumab

Sponsor:

University of Pennsylvania

Code:

NCT05669833

Conditions

Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Guselkumab

Golimumab

Study Details

Brief summary:

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

Psoriatic Arthritis

Study ID

NCT05669833

Start date

Jul 14, 2023

Status verified date

Oct, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Psoriatic arthritis meeting CASPAR criteria;
2. Active psoriatic arthritis defined by at least 1 swollen joint;
3. cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be > 14 in patients without psoriasis.
4. Using a TNFi or previously used a single TNFi historically and either never responded or lost response (TNF IR) and planning to switch to a new biologic therapy;
5. If using an oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study; Use of up to two OSM/csDMARDs is allowed.
6. If using NSAIDs, glucocorticoids (<10 mg daily) or topical medications for psoriasis, must be on a stable dose for 4 weeks prior to Screening/Baseline 1 and remain on a stable dose during the study;
7. Age 18-80 (patients older than 80 may be more likely to have concomitant osteoarthritis which may make it difficult to assess whether symptoms are related to PsA vs OA).

Exclusion Criteria:

1. Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i); prior exposure to a TYK2i is acceptable, but cannot be used during course of the study;
2. An adverse event that precludes use of another TNFi (development of drug-induced SLE, allergic reaction, serious infection, heart failure symptoms, demyelination at any point during use of therapy) or any other contraindication or substantial intolerance to a TNFi;
3. Use of moderate to high dose glucocorticoids (>10 mg);
4. Already meets the primary endpoint at Baseline; \[cDAPSA low disease activity ≤ 14; IGA of psoriasis 0/1\] In patients with psoriasis, cDAPSA can be 10-14 IF the Investigator Global Assessment of Psoriasis ≥ 2.

In patients without psoriasis, cDAPSA must be > 14 to meet eligibility requirements.
5. Currently pregnant or actively trying to conceive.

Study Design

Enrollment

63 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Guselkumab 100mg q4w

Guselkumab (GUS) 100mg every 4 weeks

experimental: Guselkumab 100mg q8w

Guselkumab (GUS) 100mg every 8 weeks

active comparator: Golimumab 50mg q4w

Golimumab (GOL) 50mg every 4 weeks

Interventions

Guselkumab

Guselkumab (GUS) subcutaneous injection

Golimumab

Golimumab (GOL) subcutaneous injection

Primary outcome measure

  • Achievement of cDAPSA low disease activity [ Time Frame: 12 Months ]
  • Investigator Global Assessment of Psoriasis of Clear or Almost Clear [ Time Frame: 12 Months ]

Central Contacts and Locations

Locations

Family Arthritis Center

Recruiting

Loxahatchee Groves, Florida, United States, 33470

Contacts

Principal Investigator:

Howard Busch, DO

Healing Rheumatology

Recruiting

Plant City, Florida, United States, 33563

Contacts

Principal Investigator:

Gina Prakash, MD

Southwest Florida Rheumatology

Recruiting

Riverview, Florida, United States, 33569

Contacts

Principal Investigator:

Shanmugapriya Reddy, MD

Parris and Associates

Recruiting

Lilburn, Georgia, United States, 30047

Contacts

Principal Investigator:

Glenn Parris, MD

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Principal Investigator:

Karen Salomon-Escoto, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Study Coordinator

bridget.kramer@unmc.edu

Principal Investigator:

Ted Mikuls, MD

New York University

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Soumya Reddy, MD

Cincy Arthritis

Recruiting

Blue Ash, Ohio, United States, 45242

Contacts

Principal Investigator:

Tara Adhikari, MD

Southern Ohio Rheumatology

Recruiting

Wheelersburg, Ohio, United States, 45694

Contacts

Principal Investigator:

Rajesh Kataria, MD

Hospital at the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Alexis Ogdie-Beatty, MD, MSCE

Cumberland Rheumatology

Recruiting

Crossville, Tennessee, United States, 38555

Contacts

Principal Investigator:

Sivalingam Kanagasegar, MD

Heritage Rheumatology and Arthritis Care

Recruiting

Colleyville, Texas, United States, 76034

Contacts

Principal Investigator:

Dhiman Basu, MD

Texas Arthritis Center

Recruiting

El Paso, Texas, United States, 79902

Contacts

Principal Investigator:

Sanjay Chabra, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Principal Investigator:

Jessica Walsh, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Keywords

  • Psoriatic Arthritis
  • PsA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-10-09.