Actively Recruiting
ConsideRAte Study - Splenic Stimulation for RA
Led by Galvani Bioelectronics · Updated on 2024-05-22
28
Participants Needed
14
Research Sites
545 weeks
Total Duration
On this page
Sponsors
G
Galvani Bioelectronics
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ConsideRAte Study - Splenic Stimulation for RA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Rheumatoid arthritis diagnosed at least six months ago according to 2010 ACR/EULAR criteria
- Male or female participants aged between 22 and 75 years
- Active rheumatoid arthritis
- Inadequate response to at least two biologic DMARDs and/or JAK inhibitors, including at least one TNF inhibitor
- Appropriate washout period from previously used biologic DMARDs or JAK inhibitors
- Currently receiving stable doses of conventional synthetic DMARDs or have documented history of failure due to ineffectiveness or intolerance
You will not qualify if you...
- Unable to provide informed consent
- Significant psychiatric illness or substance abuse
- History of unilateral or bilateral vagotomy
- Active or latent tuberculosis
- Known infection with HIV or current acute or chronic hepatitis B or C, or previous hepatitis B
- Positive COVID-19 PCR test at screening
- Implanted electrically active medical devices such as cardiac pacemakers or defibrillators
- Previous removal of the spleen (splenectomy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
Withdrawn
2
Medvin Research - Covina
Covina, California, United States, 91722
Actively Recruiting
3
Medvin Research - Whittier
Whittier, California, United States, 90602
Actively Recruiting
4
The Osteoporosis & Clinical Trials Center
Hagerstown, Maryland, United States, 21740
Actively Recruiting
5
NYU Langone
Brooklyn, New York, United States, 11201
Actively Recruiting
6
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
7
Altoona Center for Clinical Research
Altoona, Pennsylvania, United States, 16635
Actively Recruiting
8
Arthritis & Rheumatology Institute
Allen, Texas, United States, 75013
Actively Recruiting
9
St. David's Healthcare
Austin, Texas, United States, 78705
Actively Recruiting
10
Tekton Research
Austin, Texas, United States, 78745
Actively Recruiting
11
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Withdrawn
12
Southwest Rheumatology Research
Mesquite, Texas, United States, 75150
Actively Recruiting
13
Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology
Amsterdam, Netherlands
Actively Recruiting
14
Maxima Medical Center, MMC
Eindhoven, Netherlands
Actively Recruiting
Research Team
O
Operations Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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