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Rheumatoid ArthritisNCT05003310

ConsideRAte Study - Splenic Stimulation for RA

A study testing Active Stimulation, Baricitinib and Background Treatment in people with Rheumatoid Arthritis, run by Galvani Bioelectronics at 14 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Active Stimulation, Baricitinib and Background Treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
14 sitesin 2 countries
Study dates
19 Oct 2021to Apr 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Operations Director contact

+1 877 613 9001

clinical@galvani.bio

14 sites in 2 countries

United States12 sites, 10 recruiting

  • Arthritis & Rheumatology Institute

    Allen, Texas, 75013

    Study Coordinator, 972-798-8553

    Megha Patel-Banker, MD

    Recruiting

  • Altoona Center for Clinical Research

    Altoona, Pennsylvania, 16635

    Study Coordinator, 800-924-7790

    Alan Kivitz, MD

    Recruiting

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

    Withdrawn

  • St. David's Healthcare

    Austin, Texas, 78705

    SDH Office of Research; Research Dept, 512-544-8070, Krishna.Saini@stdavids.com

    Robert J. Koval, MD

    Recruiting

  • Tekton Research

    Austin, Texas, 78745

    Study Coordinator, 512-388-5717, trials@tektonresearch.com

    Paul Pickrell, MD

    Recruiting

  • NYU Langone

    Brooklyn, New York, 11201

    Galvani Operations Director, 877-613-9001, clinical@galvani.bio

    David Goddard, MD

    Recruiting

  • Medvin Research - Covina

    Covina, California, 91722

    Study Coordinator, 626-869-5730, Info@medvinresearch.com

    Samy Metyas, MD

    Recruiting

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

    Withdrawn

  • The Osteoporosis & Clinical Trials Center

    Hagerstown, Maryland, 21740

    Study Coordinator, 301-791-6680, arthritis@rheumdocs.com

    Mary Howell, MD

    Recruiting

  • Southwest Rheumatology Research

    Mesquite, Texas, 75150

    Study Coordiinator, 972-288-2600, jointpain@swrr.net

    Atul Singhal, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Cong-Qui Chu, MD, 503-494-8637

    Recruiting

  • Medvin Research - Whittier

    Whittier, California, 90602

    Study Coordinator, 562-758-6600, Info@medvinresearch.com

    Tien-I Karleen Su, MD

    Recruiting

Other trials in United States

Netherlands2 sites, 2 recruiting

  • Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology

    Amsterdam

    Study Coordinator

    Sander Tas, MD

    Recruiting

  • Maxima Medical Center, MMC

    Eindhoven

    Jasper Broen, MD

    Recruiting

Other trials in Netherlands

About this study

Official title: Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis

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.

Read the 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.

Being tested
Active Stimulation, Sham Stimulation, Baricitinib, Background Treatment
Keywords
Electrical stimulation, random allocation, inflammation, active implantable medical device, Laparoscopy, antirheumatic agents, autonomic nervous system, feasibility studies
Medical subject headings
Arthritis, Rheumatoid, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active StimulationDevice

    Stimulation will be turned ON and applied during each day of the period.

  • Sham StimulationDevice

    Sham stimulation will be provided during the period

  • BaricitinibDrug

    Baricitinib (2 mg) is administered daily during the period.

  • Background TreatmentDrug

    Stable dose of standard background treatment (e.g., csDMARD therapy)

Study groups in NCT05003310
Study groupRoleWhat they receive
Active Stimulation; Period 1ExperimentalActive stimulation for 12 weeks
Receives: Device: Active Stimulation; Drug: Background Treatment
Sham Stimulation; Period 1Sham comparatorSham stimulation for 12 weeks
Receives: Device: Sham Stimulation; Drug: Background Treatment
Open label active stimulation, Period 2ExperimentalOpen label active stimulation for 12 additional weeks
Receives: Device: Active Stimulation; Drug: Background Treatment
Open label RA Drug, Period 2OtherOpen label drug treatment with baricitinib for 12 weeks
Receives: Drug: Baricitinib; Drug: Background Treatment
RA drug combined with active stimulation, Period 3ExperimentalParticipants on baricitinib during Period 2 will have active stimulation added for 24 weeks
Receives: Device: Active Stimulation; Drug: Baricitinib; Drug: Background Treatment
Active stimulation combined with RA drug, Period 3ExperimentalParticipants on active stimulation during Period 2 will have baricitinib added for 24 weeks
Receives: Device: Active Stimulation; Drug: Baricitinib; Drug: Background Treatment
Long-term Follow-up, Period 4OtherStandard of care treatments with or without stimulation
Receives: Device: Active Stimulation; Drug: Background Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events [Safety and Tolerability]

    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

    Measured: Up through the end of Period 1 (Period 1 is up to 12 weeks duration)

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Measured: During Period 2 (Period 2 is up to 12 weeks in duration beyond Period 1)

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Measured: During Period 3 (Period 3 is up to 24 weeks in duration beyond Period 2)

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Measured: During Period 4 (Period 4 is up to 5 years in duration beyond Period 3)

Secondary outcomes (36)

  1. Change in the 28 Joint Disease Activity Score 28 - C reactive protein (DAS28-CRP)

    Measured: Baseline to 12 weeks (Period 1)

  2. Change in the level of Lipopolysaccharide (LPS)-inducible release of Tumor Necrosis Factor (TNFα) in whole blood assay

    Measured: Baseline to 12 weeks (Period 1)

  3. Change in the level of LPS-inducible release of TNFα in whole blood assay

    Measured: Baseline to 24 weeks (Period 2)

  4. Change in the level of LPS-inducible release of Interleukin 6 (IL-6) in whole blood assay

    Measured: Baseline to 12 weeks (Period 1)

  5. Change in the level of LPS-inducible release of Interleukin 6 (IL-6) in whole blood assay

    Measured: Baseline to 24 weeks (Period 2)

  6. Change in the level of LPS-inducible release of IL-8 in whole blood assay

    Measured: Baseline to 12 weeks (Period 1)

  7. Change in the level of LPS-inducible release of IL-8 in whole blood assay

    Measured: Baseline to 24 weeks (Period 2)

  8. Change in the level of LPS-inducible release of IL-17 in whole blood assay

    Measured: Baseline to 12 weeks (Period 1)

  9. Change in the level of LPS-inducible release of IL-17 in whole blood assay

    Measured: Baseline to 24 weeks (Period 2)

  10. Change in DAS28-CRP

    Measured: Baseline to 24 weeks (Period 2)

  11. Change in DAS28-CRP

    Measured: Baseline to 36 weeks (Period 3)

  12. Change in DAS28-CRP

    Measured: Baseline to 48 weeks (Period 3)

  13. Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score

    Measured: Baseline to 12 weeks (Period 1)

  14. Change in HAQ-DI score

    Measured: Baseline to 24 weeks (Period 2)

  15. Change in HAQ-DI score

    Measured: Baseline to 36 weeks (Period 3)

  16. Change in HAQ-DI score

    Measured: Baseline to 48 weeks (Period 3)

  17. Change in Short Form 36 (SF-36) physical component score

    Measured: Baseline to 12 weeks (Period 1)

  18. Change in SF-36 physical component score

    Measured: Baseline to 24 weeks (Period 2)

  19. Change in SF-36 physical component score

    Measured: Baseline to 36 weeks (Period 3)

  20. Change in SF-36 physical component score

    Measured: Baseline to 48 weeks (Period 3)

  21. Change in SF-36 mental component score

    Measured: Baseline to 12 weeks (Period 1)

  22. Change in SF-36 mental component score

    Measured: Baseline to 24 weeks (Period 2)

  23. Change in SF-36 mental component score

    Measured: Baseline to 36 weeks (Period 3)

  24. Change in SF-36 mental component score

    Measured: Baseline to 48 weeks (Period 3)

  25. Change in SF-36 domain score

    Measured: Baseline to 12 weeks (Period 1)

  26. Change in SF-36 domain score

    Measured: Baseline to 24 weeks (Period 2)

  27. Change in SF-36 domain score

    Measured: Baseline to 36 weeks (Period 3)

  28. Change in SF-36 domain score

    Measured: Baseline to 48 weeks (Period 3)

  29. To evaluate the usability of the external Galvani System devices and accessories

    Summarize feedback collected on a questionnaire pertaining to the use of the external Galvani System devices

    Measured: Through 48 weeks

  30. To evaluate the participants' perception of therapy and sensation

    A form is provided to participants at each visit after randomization to describe any sensations that may be associated with the Galvani System

    Measured: Through 48 weeks

  31. Evaluate device performance as assessed by tabulation of device deficiencies

    Measured: Through 48 weeks

  32. Change in DAS28-CRP in participants who remain on active stimulation during Period 2

    Measured: week 12 to week 24

  33. Incidence of participants who remain on active stimulation achieving DAS28-CRP score <2.6 at the end of Period 2

    Measured: Time Frame: Week 24

  34. Change in DAS28-CRP in participants who are given Drug treatment with baricitinib during Period 2

    Measured: week 12 to week 24

  35. Incidence of a change in DAS28-CRP greater than 1.2 units in participants who are given Drug treatment with baricitinib during Period 2

    Measured: week 12 to week 24

  36. Incidence of participants who are given drug treatment with baricitinib achieving DAS28-CRP score <2.6 at the end of Period 2

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start19 Oct 2021
  3. Primary completionJul 2027 (estimated)
  4. Study completionApr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003310
Sponsor's protocol ID
GAL1040
Status last verified
May 2024
First submitted
5 Jul 2021
Last updated
22 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Tas SW, Christiaans J, Boumans MJH, Koopman FA, Pickrell P, Goddard DH, Kivitz A, Patel-Banker M, Chu CQ, Lee E, Wickersham P, Alli VV, Faulkenberry TL, Jenkins M, Winder J, Luyer MDP, Barnett C, Famm K, Irwin E, Kwong K, Scribner LL, Milliken PH, Raji O, Rall K, Sokal DM, Whiteman H, Mahmood A, Vervoordeldonk MJ, Gupta I, Abdulai RM, Broen JCA. Splenic neuromodulation as monotherapy and in combination with biologic or targeted synthetic DMARDs for difficult-to-treat rheumatoid arthritis (ConsiderRAte): a randomised, sham-controlled, early feasibility trial. EClinicalMedicine. 2026 Aug 6;98:104133. doi: 10.1016/j.eclinm.2026.104133. eCollection 2026 Aug.

    PubMed 42602670

Questions about this trial

What is this clinical trial studying?

A study testing Active Stimulation, Baricitinib and Background Treatment in people with Rheumatoid Arthritis, run by Galvani Bioelectronics at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Operations Director (+1 877 613 9001, clinical@galvani.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events [Safety and Tolerability] (time frame: Up through the end of Period 1 (Period 1 is up to 12 weeks duration)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05003310, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.

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ConsideRAte Study - Splenic Stimulation for RA | AzTrials