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