Rheumatoid Arthritis Clinical Trial
Official title:
Researching the Safety and Efficacy the Vorso PROTECT System for the Treatment of Subjects With Active Rheumatoid Arthritis Who Are naïve to Biologic or Synthetic Disease Modifying Agents
This is a prospective, multi-center, double-blind, randomized, controlled pilot study to assess safety and efficacy of the Vorso PROTECT System in patients who have moderately to severely active rheumatoid arthritis. Eligible participants will be randomized in a 1:1 ratio of treatment to control (non- therapeutic) group after it has been determined they meet all of the inclusion criteria and none of the exclusion criteria. Both the treatment and control group participants will be asked to use the VORSO System once a day while maintaining a stable dose of methotrexate throughout the 12-week study. Participants will return to the site at 1, 6 and 12 weeks for follow-up testing.
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