NCT05669833

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary aim of the trial will be to determine, among psoriatic arthritis (PsA) patients with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi), whether switching to a new mechanism of action (MOA), specifically guselkumab (GUS), a selective interleukin 23 inhibitor (IL23i) targeting the p19 subunit, is more effective than switching to another TNFi. The primary hypothesis of this study is that switching to a new MOA may be more effective than switching to a second TNFi. This will be the first trial to test such a switch in PsA patients. Additionally, the proposed study will address the effectiveness of a new therapy, GUS, in a clinical practice setting among patients who are TNF IR.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Guselkumab	Guselkumab (GUS) subcutaneous injection
DRUG	Golimumab	Golimumab (GOL) subcutaneous injection

Timeline

• Start date: 2023-07-14
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-01-03
• Last updated: 2025-10-09

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study