ConsideRAte Study - Splenic Stimulation for RA
Purpose
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.
Condition
- Rheumatoid Arthritis
Eligibility
- Eligible Ages
- Between 22 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- RA of at least six months duration, per 2010 ACR/EULAR criteria - Male or female participants, 22-75 years of age - Active RA - Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor - Have an appropriate washout from previously used biological DMARDs or JAKi - Receiving current treatment with standard dose(s) of conventional synthetic DMARD(s) or have documented history of failure due to ineffectiveness or intolerance
Exclusion Criteria
- Inability to provide informed consent - Significant psychiatric disease or substance abuse - History of unilateral or bilateral vagotomy - Active or latent tuberculosis - Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B - Positive SARS COV 2 PCR screening test for COVID-19 infection (at the point of screening for this study) - Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators) - Previous splenectomy
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Multicenter study with 4 periods. Period 1 is a randomized, controlled double-blind period where participants are assigned randomly to either active or sham stimulation. During the open-label Periods 2 through 4, participants are assigned treatment based on responses to treatments in the prior period
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active Stimulation; Period 1 |
Active stimulation for 12 weeks |
|
|
Sham Comparator Sham Stimulation; Period 1 |
Sham stimulation for 12 weeks |
|
|
Experimental Open label active stimulation, Period 2 |
Open label active stimulation for 12 additional weeks |
|
|
Other Open label RA Drug, Period 2 |
Open label drug treatment with baricitinib for 12 weeks |
|
|
Experimental RA drug combined with active stimulation, Period 3 |
Participants on baricitinib during Period 2 will have active stimulation added for 24 weeks |
|
|
Experimental Active stimulation combined with RA drug, Period 3 |
Participants on active stimulation during Period 2 will have baricitinib added for 24 weeks |
|
|
Other Long-term Follow-up, Period 4 |
Standard of care treatments with or without stimulation |
|
Recruiting Locations
Covina, California 91722
Whittier, California 90602
Hagerstown, Maryland 21740
Brooklyn, New York 11201
Portland, Oregon 97239
Cong-Qui Chu, MD
503-494-8637
Altoona, Pennsylvania 16635
Study Coordinator
800-924-7790
Allen, Texas 75013
Study Coordinator
972-798-8553
Austin, Texas 78705
Austin, Texas 78745
Mesquite, Texas 75150
More Details
- Status
- Recruiting
- Sponsor
- Galvani Bioelectronics
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.