ConsideRAte Study - Splenic Stimulation for RA (NCT05003310)
Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis
🩺 Plain-English Summary (8th-Grade Level)
This study will evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. The study will consist of 4 study periods, including a Randomized Control Trial period (Period 1), an Open Label period (Period 2), a Treat-to-target period (Period 3), and a Long-term Follow-up period (Period 4). Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). A sufficient number of participants will be enrolled so that approximately 28 participants will undergo device implantation.
Who can join: Review the eligibility criteria below.
Location: Pinnacle Research Group, LLC — Anniston, Alabama
Age range: 22 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- Pinnacle Research Group, LLC — Anniston, Alabama
- Medvin Research - Covina — Covina, California
- Medvin Research - Whittier — Whittier, California
- The Osteoporosis & Clinical Trials Center — Hagerstown, Maryland
- NYU Langone — Brooklyn, New York
- Oregon Health & Science University — Portland, Oregon
- Altoona Center for Clinical Research — Altoona, Pennsylvania
- Arthritis & Rheumatology Institute — Allen, Texas
- St. David's Healthcare — Austin, Texas
- Tekton Research — Austin, Texas
- Metroplex Clinical Research Center — Dallas, Texas
- Southwest Rheumatology Research — Mesquite, Texas
- Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology — Amsterdam,
- Maxima Medical Center, MMC — Eindhoven,
📞 Contact the Study Coordinator
Phone: (877) 613-9001
Email: clinical@galvani.bio
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rheumatoid Arthritis
- Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to a DMARD Starting a New bDMARD or tsDMARD Treatment +/- csDMARD — Phoenix, Arizona
- A Clinical Study to Assess the Efficacy of Cannabigerol in Patients with Active Rheumatoid Arthritis. — Santa Monica, California
- Employment and Arthritis: Making it Work — Richmond, British Columbia
- Brigham and Women's Rheumatoid Arthritis Sequential Study — Boston, Massachusetts
- A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR) — Flagstaff, Arizona
- A Study of SPY072 in Rheumatic Disease — Avondale, Arizona
Explore by condition: All Rheumatoid Arthritis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.