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NCT05003310 · ClinicalTrials.gov registry record · NA
ConsideRAte Study - Splenic Stimulation for RA
A NA study of Rheumatoid Arthritis, sponsored by Galvani Bioelectronics.
- Recruiting
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 14
- Study locations
NCT05003310: Recruiting NA study of Rheumatoid Arthritis, sponsored by Galvani Bioelectronics.
NCT05003310 is a NA study of Rheumatoid Arthritis that is actively recruiting participants, run by Galvani Bioelectronics. The registered enrollment target is 28 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 14 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05003310, a NA study of Rheumatoid Arthritis, is actively recruiting participants, sponsored by Galvani Bioelectronics.
- RECRUITING
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 14
- Study locations
Study 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.
Primary Outcome
Adverse Events (AEs) may include clinically significant findings from Laboratory Safety Assessments (clinical chemistry and hematology), vital signs (blood pressure, heart rate, respiratory rate, and body temperature), and 12-Lead EKG
Conditions Studied
Interventions
- DRUG Baricitinib
- DEVICE Sham Stimulation
- DEVICE Active Stimulation
- DRUG Background Treatment
Study Locations (14)
Texas
- Arthritis & Rheumatology Institute - Allen
- St. David's Healthcare - Austin
- Tekton Research - Austin
- Metroplex Clinical Research Center - Dallas
- Southwest Rheumatology Research - Mesquite
California
- Medvin Research - Covina - Covina
- Medvin Research - Whittier - Whittier
Other
- Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology - Amsterdam
- Maxima Medical Center, MMC - Eindhoven
Alabama
- Pinnacle Research Group, LLC - Anniston
Maryland
- The Osteoporosis & Clinical Trials Center - Hagerstown
New York
- NYU Langone - Brooklyn
Oregon
- Oregon Health & Science University - Portland
Pennsylvania
- Altoona Center for Clinical Research - Altoona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2032-04 |
| Phase | NA |
What NCT05003310 shows while recruiting
NCT05003310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 4 interventions - of which Baricitinib is the first listed.
NCT05003310 lists 14 locations in 8 states (Texas, California, Other).
Frequently Asked Questions
What is clinical trial NCT05003310 about?
NCT05003310 is a clinical study titled "ConsideRAte Study - Splenic Stimulation for RA". 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 ...
What is the current status of trial NCT05003310?
This trial is currently recruiting. It is a NA study. The enrollment target is 28 participants. The study started on 2021-10-19. Estimated completion is 2032-04.
What conditions does trial NCT05003310 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT05003310?
The interventions under investigation include: Baricitinib (DRUG), Sham Stimulation (DEVICE), Active Stimulation (DEVICE), Background Treatment (DRUG).
Who is sponsoring clinical trial NCT05003310?
This trial is sponsored by Galvani Bioelectronics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05003310 being conducted?
This trial has 14 study locations across Alabama, California, Maryland, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05003310's enrollment target sits among peer trials
28 166th of 197 higher than 32 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
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