NCT05003310

ConsideRAte Study - Splenic Stimulation for RA

Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Galvani Bioelectronics · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Participants with active rheumatoid arthritis (RA) who receive the implantable system will be randomly assigned to receive either active stimulation or sham-stimulation for 12 weeks (Period 1). Following Period 1, all participants will enter an open label phase (Period 2) during which participants who responded to stimulation will continue on stimulation; whereas participants who received sham stimulation, or were stimulation non-responders, will receive a market-approved RA drug for 12 weeks. At the end of Period 2, participants who respond to their Period 2 therapy but still exhibit signs and symptoms of RA will enter the Treat-to-target period (Period 3); others will proceed to Period 4 (Long-term Follow-up). During the Treat-to-Target period, participants will be treated with dual therapy (stimulation in combination with the market-approved RA drug) for up to 24 weeks. Period 4 provides long term safety follow up for all study participants for a period of 5 years. Participants may receive stimulation in combination with other approved and standard of care therapies, subject to a favorable benefit-risk assessment in the judgement of the treating rheumatologist.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Active Stimulation	Stimulation will be turned ON and applied during each day of the period.
DEVICE	Sham Stimulation	Sham stimulation will be provided during the period
DRUG	Baricitinib	Baricitinib (2 mg) is administered daily during the period.
DRUG	Background Treatment	Stable dose of standard background treatment (e.g., csDMARD therapy)

Timeline

• Start date: 2021-10-19
• Primary completion: 2027-07-01
• Completion: 2032-04-01
• First posted: 2021-08-12
• Last updated: 2024-05-22

Locations

14 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated device study