RecruitingPhase 3NCT05669833
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)
Sponsor
University of Pennsylvania
Enrollment
63 participants
Start Date
Jul 14, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria7
- 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).
Exclusion Criteria6
- 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.
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Interventions
DRUGGuselkumab
Guselkumab (GUS) subcutaneous injection
DRUGGolimumab
Golimumab (GOL) subcutaneous injection
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05669833
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