ABOUT THE STUDY
Why are we conducting this study?
Psoriatic arthritis (PsA) is an inflammatory arthritis (i.e., there is joint swelling and inflammation) that occurs in up to 1/3 of patients with psoriasis. This can be a devastating disease for some and can be relatively mild for others.
People living with this condition have lots of treatment options, but it remains unclear how to utilize the treatments we have available. Our goal is to figure out how to optimize therapy for each individual, particularly people who are not doing as well as hoped on their first therapy.
The goal of this study is to improve outcomes in PsA by changing the way we study and manage the disease. The head-to-head, pragmatic study design will allow us to compare effectiveness of two therapies in a broader patient population and capture more treatment outcomes that are meaningful for patients with PsA. This will better inform decision making and implementation in clinical practice.
Design
The purpose of the study is to determine the most effective treatment for people with psoriatic arthritis who either didn't respond or lost response to a biologic therapy known as a Tumor Necrosis Factor inhibitor (TNFi) such as Enbrel, Humira, Cimzia, or Remicade. It's not known whether after a first TNFi you should switch to a similar therapy or a different type of biologic therapy. This trial tests this question by randomizing which therapy is received. Specifically, we are studying whether, after loss of response to a first TNFi, switching to an IL23i is more effective than switching to a second TNFi.
We will recruit 150 participants at study centers throughout the United States.
If you are eligible to enroll in the EVOLUTION study, you will be randomly assigned a therapy - either guselkumab (Tremfya, an IL23i) or golimumab (Simponi, a TNFi). Your study medication will be shipped directly to your home from the study pharmacy. 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 also complete online questionnaires every 4 weeks to tell us how you're doing.
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INTERESTED?
Please complete this contact form!
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Someone on our study team will follow up with you as soon as possible!