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Tests treatment safety and results for Rheumatoid Arthritis
Official title Safety of Splenic Stimulation for RA
ClinicalTrials.gov ID: NCT04955899
What this study is testing
- What it's testing
- This study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join if
- Adult-onset RA of at least six months duration
- Male or female participants, 22-75 years of age
- Active RA
- Inadequate Response to at least 2 biologic DMARDs and/or JAK- inhibitors (JAKis)
- Have an appropriate washout from previously used biological DMARDs or JAKi
You likely can't join if
- 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.
- Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators).
See the full eligibility criteria
- Adult-onset RA of at least six months duration
- Male or female participants, 22-75 years of age
- Active RA
- Inadequate Response to at least 2 biologic DMARDs and/or JAK- inhibitors (JAKis)
- Have an appropriate washout from previously used biological DMARDs or JAKi
- A female participant should have no child-bearing potential
- 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.
- Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators).
- Previous splenectomy
- Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery.
- Uncontrolled other inflammatory diseases
- Current/recurrent infections that in the opinion of the PI risk\>benefit.
- History of cancer within the past 5 years, except non-malignant skin cancer.
- Chronic use of morphine or oxicodone
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Glasgow, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Glasgow, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.