Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Recruiting now · Phase 3

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT05669833

Run by

University of Pennsylvania

People needed

63

Starts

2023-07-14

Expected to finish

2026-10-01

Last updated by the study team

2025-10-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Psoriatic arthritis meeting CASPAR criteria;
• Active psoriatic arthritis defined by at least 1 swollen joint;
• cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be > 14 in patients without psoriasis.
• 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;
• 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.
• 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;
• 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).

You may not qualify if…

• 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;
• 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;
• Use of moderate to high dose glucocorticoids (>10 mg);
• 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.
• Currently pregnant or actively trying to conceive.

Where it is running

• Family Arthritis Center — Loxahatchee Groves, Florida, United States (enrolling)
• Healing Rheumatology — Plant City, Florida, United States (enrolling)
• Southwest Florida Rheumatology — Riverview, Florida, United States (enrolling)
• Parris and Associates — Lilburn, Georgia, United States (enrolling)
• University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• New York University — New York, New York, United States (enrolling)
• Cincy Arthritis — Blue Ash, Ohio, United States (enrolling)
• Southern Ohio Rheumatology — Wheelersburg, Ohio, United States (enrolling)
• Hospital at the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Cumberland Rheumatology — Crossville, Tennessee, United States (enrolling)
• Heritage Rheumatology and Arthritis Care — Colleyville, Texas, United States (enrolling)
• Texas Arthritis Center — El Paso, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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