EVOLUTION Study

Guselkumab vs golimumab in TNFi inadequate responder psoriatic arthritis patients

(Now recruiting)

Type

Interventional – treatment

Randomized, pragmatic, open-label, Phase III-B clinical trial. The study drugs are guselkumab (Tremfya) and golimumab (Simponi), which are both approved by the U.S. Food and Drug Administration (FDA) for treatment of active psoriatic arthritis in adults.

Purpose

Psoriatic arthritis (PsA) is a chronic inflammatory arthritis associated with substantial fatigue, pain, joint stiffness, and diminished function. People living with this condition have lots of treatment options, but it remains unclear how to best utilize the treatments we have available. Our goal is to figure out how to optimize therapy for each individual and improve outcomes in PsA by changing the way we study and manage the disease.

The purpose of the study is to determine the most effective treatment for people with psoriatic arthritis (PsA) who have either stopped responding to or didn’t respond to a TNFi (Tumor Necrosis Factor inhibitor) such as Humira, Enbrel, Cimzia, or Remicade. Specifically, we are studying whether, after loss of response or lack of response to a TNFi, switching to an IL23i (Interleukin-23 inhibitor) is more effective than switching to a different TNFi.

Participants will be randomized to receive either guselkumab (Tremfya, an IL23i) or golimumab (Simponi, a TNFi).

Eligibility

You may be eligible for this study if you:

Are aged 18-80;
Have been diagnosed with psoriatic arthritis;
Are currently on a TNFi or have tried a TNFi in the past; and
Still have some disease activity.

Participation

Participants will be randomized to receive either guselkumab (Tremfya, an IL23i) or golimumab (Simponi, a TNFi). The study is open-label - both you and your physician will know which medication you are receiving.

You will be followed over the course of one year at your usual clinical visits, with full skin and joint examinations at Baseline, 6 Months, and 12 Months.

You will complete online questionnaires every 4 weeks to document your study drug injections and to tell us how you’re doing.

You will receive compensation for your time at both the in-person and remote study visits.