Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The trial is a double-blinded randomized study with three arms: Golimumab (GOL) 50 mg subcutaneous injection every 4 weeks, guselkumab (GUS) 100 mg subcutaneous injection every 8 weeks, and GUS 100 mg every 4 weeks. It 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Golimumab

Criteria

Inclusion Criteria:

1. Psoriatic arthritis meeting CASPAR criteria;

2. 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 (this captures the majority of patients switching therapy in our cohort);

3. At least one active psoriasis plaque;

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 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.

6. 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;

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);

2. An adverse event the 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 meet the primary outcome at screening or baseline