Splenic Stimulation for Rheumatoid Arthritis
ConsideRAte Study - Splenic Stimulation for RA
Recruiting
N/A
Interventional Study
Rheumatoid Arthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 28 (estimated)
- Sponsor
- Galvani Bioelectronics · Industry
Who this trial is looking for
This trial is looking for people with rheumatoid arthritis that hasn’t improved with other treatments. Participants will receive stimulation therapy using a special device to see if it helps their condition.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with rheumatoid arthritis for at least six months.
- I am between 22 and 75 years old.
- I have active rheumatoid arthritis.
- I have not responded to at least two biologic DMARDs or JAK inhibitors.
- I have completed a washout period from previous treatments.
- I am currently taking standard doses of conventional synthetic DMARDs.
You may not be able to join if
- I cannot provide informed consent.
- I have significant psychiatric disease or substance abuse.
- I have had vagotomy surgery.
- I have active or latent tuberculosis.
- I am infected with HIV or have hepatitis B or C.
- I tested positive for COVID-19 during screening.
- I have an electrically active medical device implanted.
- I have had my spleen removed.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 fr…
Contacts