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Not Yet Recruiting NCT05669833

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Conditions: Psoriatic Arthritis

Sex: All
Ages: 18 Years – 80 Years
Phase: PHASE3
Enrollment: 300
Sponsor: University of Pennsylvania

Location: United States

Summary

The trial is a double-blinded 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.

Eligibility Criteria

Inclusion Criteria:Psoriatic arthritis meeting CASPAR criteria;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 jointsAt least one active psoriasis plaque;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 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.If using NSAIDs, glucocorticoids (<10 mg daily) or topical medications for psoriasis, must be on a stable dose for 4 weeks and remain on a stable dose during the study;age 18-80Exclusion Criteria:Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i);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 meet the primary outcome at screening or baselineCurrently pregnant or actively trying to conceive

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05669833). StuddyBuddy aggregates publicly available trial information.