FDA Approves Continuation of SetPoint Medical’s Study on RA Patients
The FDA has approved SetPoint Medical’s continuation of its study evaluating vagus nerve stimulation for patients with rheumatoid arthritis.
The company had first received the green light in Jan. 2021 from the FDA in the form of an investigational device exemption to evaluate its proprietary therapeutic platform in this patient population.
The company said the study is intended to evaluate the efficacy and safety of this therapy in patients with moderate-to-severe rheumatoid arthritis who are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs.
The study is designed to enroll up to 250 patients at 40 sites across the U.S. in two stages. The FDA approved the study continuation with no changes to the study protocol after its review of both safety and efficacy outcomes from the stage 1 portion of the study, which involved the enrollment of 60 patients at 18 sites in the U.S., completed in March 2022.