This is a device that hasn’t been approved by the United States Food & Drug Administration (FDA)
Clinical Research Study for Rheumatoid Arthritis
Seeking rheumatoid arthritis patients for new study
If you have rheumatoid arthritis (RA) and still can’t find relief from your symptoms, you could be a candidate for this research study. Researchers are evaluating a new investigational medical device help_outline that may improve moderate to severe RA symptoms using nerve stimulation.
Caution: Investigational device. Limited by United States law to investigational use.
This is a device that hasn’t been approved by the United States Food & Drug Administration (FDA)
Enrolling now!
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Patients who have moderate to severe rheumatoid arthritis
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58 weeks plus 5 years of long-term follow-up
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Sites available in several cities in the United States
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Study-related care & travel compensation may be available
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Involves surgery to implant the investigational device
Exploring novel potential treatments for rheumatoid arthritis
This study is sponsored by Galvani Bioelectronics. You can find more information at www.galvani.bio. Verily Life Sciences (Verily) is collecting data on behalf of Galvani for the purpose of recruitment for the Rheumatoid Arthritis Study. Data captured for the purposes of the Rheumatoid Arthritis Study will be governed by the Galvani Bioelectronics Privacy Policy. Website cookies and information captured for the purposes of website performance are governed by the Baseline Privacy Policy.
Who’s eligible
22-75 years of age
Adult-onset rheumatoid arthritis diagnosed for at least six months (see FAQ)
Willingness to have surgery for an implantable device (like a pacemaker)
Body mass index (BMI) of less than 33
Have rheumatoid arthritis symptoms despite trying multiple medications help_outline
Medications include:
- Actemra® (tociluzumab)
- Cimzia® (certolizumab pegol)
- Enbrel® (etanercept)
- Humira® (adalimumab)
- Kevzara® (sarilumab)
- Kineret® (anakinra)
- Orencia® (abatacept)
- Remicade® (infliximab)
- Rinvoq® (upadacitinib)
- Rituxan® (rituximab)
- Simponi® (golimumab)
- Simponi Aria® (golimumab)
- Xeljanz® (tofacitinib)
- Xeljanz XR® (tofacitinib)
NOT pregnant, breastfeeding, or planning to become pregnant
See if you may qualify by reaching out today
If you have moderate or severe rheumatoid arthritis and are interested in potentially joining this research study, reach out to the team today.
What’s involved
This study involves placing an investigational medical device help_outline (like a pacemaker) in the body to stimulate a nerve near your spleen help_outline and evaluate its effects on rheumatoid arthritis symptoms.
Participating in a research study is completely voluntary. If you decide to participate in this study — or any research study — you are free to withdraw at any time and for any reason without it affecting your ongoing medical care.
Consent and screening
Discuss the study expectations, risks, and potential benefits with the study doctor; sign the consent form(s) if you agree to participate. Then undergo screening activities (medical assessments that help determine if you are a candidate) which may take up to 6 weeks to complete.
Implantation surgery and recovery
If screening shows you qualify, you may undergo surgery to implant the investigational medical device help_outline, stay overnight at the hospital, and then rest and recover at home (for at least 4 weeks).
This is a device that hasn’t been approved by the United States Food & Drug Administration (FDA)
Treatment periods (up to 48 weeks)
After the implant, you may receive study treatment (nerve stimulation) and/or other medications based on how you feel and the outcome of study assessments.
Long-term follow-up
After the initial treatment periods, you will receive follow-up care for up to 5 years. In addition to ongoing safety assessments, you may continue to receive study treatment and/or other standard rheumatoid arthritis medications.
What you’ll receive
By participating in this study, you may receive study-related medical care and help researchers evaluate if the investigational medical device help_outline can help manage your symptoms of rheumatoid arthritis.
There are risks associated with this study – such as risks associated with surgery (like bleeding or infection) and using the investigational medical device help_outline (like sensation during use). Additional information will be provided in the informed consent document.
Investigational medical device help_outline and study-related care This is a device that hasn’t been approved by the United States Food & Drug Administration (FDA)
This is a device that hasn’t been approved by the United States Food & Drug Administration (FDA)
You may receive keyhole surgery to implant the investigational medical device help_outline and study-related care. Depending on the outcome of study assessments, you may also receive baricitinib (OLUMIANT), an FDA-approved therapy for rheumatoid arthritis. The study doctor will discuss these treatment options and associated precautions with you.
Study-related care and travel
You may be compensated for study-related care and travel that you may be required to do in this study.
More information about the study
If eligible to participate, you will receive detailed information from the study team about the study, including possible risks to your health and study activities. You will be given consent forms that also describe this information.
Learn more about this rheumatoid arthritis study
See if you qualify for the Clinical Research Study for Rheumatoid Arthritis today.
Clinical Research Study for Rheumatoid Arthritis
Study FAQs
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The Clinical Research Study for Rheumatoid Arthritis is evaluating the safety and feasibility of implanting an investigational medical device help_outline that stimulates the splenic nerve, and monitoring the effects of this stimulation on rheumatoid arthritis symptoms.
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Clinical Research Study for Rheumatoid Arthritis is sponsored by Galvani Bioelectronics.
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While the length of the study may change based on how you feel and the outcome of study assessments, the initial period will be approximately 1 year 58 weeks, followed by a 5-year long-term follow-up period.
Note: Participating in a research study is completely voluntary. If you decide to participate in this study — or any research study — you are free to withdraw at any time and for any reason without it affecting your ongoing medical care.
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Participation is voluntary. Here are some of the key criteria:
- Age 22 - 75 years
- Diagnosed with adult-onset rheumatoid arthritis for six months or longer
- Still experiencing symptoms of rheumatoid arthritis even though you have tried different medications
- Body mass index (BMI) of less than 33
- For Female Participants Only: A female participant is eligible to participate if she is not pregnant or breastfeeding or planning on becoming pregnant
Note: There are additional eligibility criteria. The study doctor will determine if you qualify after an examination. More information is available here: https://clinicaltrials.gov/ct2/show/NCT05003310
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Participation is voluntary. You are not eligible to join the Clinical Research Study for Rheumatoid Arthritis if you have:
- Prior use of, or inability to use, OLUMIANT (baricitinib)
- Fibromyalgia
- Currently implanted with electrically-active medical devices (e.g. cardiac pacemakers, automatic implantable cardioverter-defibrillators)
- Active or latent tuberculosis
- Previous splenectomy (surgery to remove the spleen)
Note : There are additional eligibility criteria. The study doctor will determine if you qualify after an examination. More information is available here: https://clinicaltrials.gov/ct2/show/NCT05003310
Caution: Investigational device. Limited by United States law to investigational use.