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ConsideRAte Study - Splenic Stimulation for RA

NCT05003310 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-05-22

No results posted yet for this 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

Interventions

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)

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Q2 Solutions

    collaborator INDUSTRY

  • Galvani Bioelectronics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2027-07-31
Completion
2032-04-30
FDA Device
Yes

Countries

  • United States
  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05003310 on ClinicalTrials.gov