Back to Trials
NCT05669833PHASE3Recruiting

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

University of Pennsylvania

Start Date

7/14/2023

Completion Date

10/1/2026

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.

Detailed Description

The primary aim of the trial will be to determine, among psoriatic arthritis (PsA) patients with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi), whether switching to a new mechanism of action (MOA), specifically guselkumab (GUS), a selective interleukin 23 inhibitor (IL23i) targeting the p19 subunit, is more effective than switching to another TNFi. The primary hypothesis of this study is that switching to a new MOA may be more effective than switching to a second TNFi. This will be the first trial to test such a switch in PsA patients. Additionally, the proposed study will address the effectiveness of a new therapy, GUS, in a clinical practice setting among patients who are TNF IR.

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

DRUG

Guselkumab

DRUG

Golimumab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Psoriatic Arthritis

Locations

Family Arthritis Center

Loxahatchee Groves, Florida 33470

United States

Healing Rheumatology

Plant City, Florida 33563

United States

Southwest Florida Rheumatology

Riverview, Florida 33569

United States

Parris and Associates

Lilburn, Georgia 30047

United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts 01655

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

New York University

New York, New York 10016

United States

Cincy Arthritis

Blue Ash, Ohio 45242

United States

Southern Ohio Rheumatology

Wheelersburg, Ohio 45694

United States

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Cumberland Rheumatology

Crossville, Tennessee 38555

United States

Heritage Rheumatology and Arthritis Care

Colleyville, Texas 76034

United States

Texas Arthritis Center

El Paso, Texas 79902

United States

University of Utah

Salt Lake City, Utah 84132

United States