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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 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.

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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.

Conditions Studied

Rheumatoid Arthritis

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

FieldValue
Enrollment Target 28 participants
Start Date 2021-10-19
Est. Completion 2032-04
Phase NA

Sponsor

Galvani Bioelectronics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05003310

The ClinicalTrials.gov registry entry for NCT05003310 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The listed sponsor is Galvani Bioelectronics, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 14 study locations spanning 8 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.