Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)
Psoriatic Arthritis
About this trial
This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, PsA
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 joints At 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 18-80 Exclusion 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 baseline Currently pregnant or actively trying to conceive
Sites / Locations
- Hospital at the University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
GUS
GUS and Placebo
GOL
Guselkumab (GUS)
Guselkumab (GUS) and Matching Placebo
Golimumab (GOL)