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What To Expect While Participating In The RESET-RA Study

What To Expect During The Study for Vagus Nerve Stimulation for RA

If you take the qualification survey on our website and are found to potentially meet the criteria for participation in the RESET-RA Study, evaluating vagus nerve stimulation for RA, a multi-step process follows. The process will help determine your eligibility to participate in the study, equip you with the right information to make an informed decision, and, ultimately, enroll you in the study to implant the MicroRegulator device.

What are the initial steps involved in participating?

First, you’ll have a call with a healthcare professional at our call center to confirm your potential eligibility and interest in participating, and answer any questions you have at this time. The call center will then connect you with a study coordinator near you to schedule an appointment for you at your nearest study location. The study coordinator and doctor at the site will share more information with you about the study, and confirm your eligibility to participate. You’ll receive an informed consent form, complete symptom questionnaires, get interviewed by the study doctor, undergo a joint count exam to determine your current disease state, complete blood tests, and undergo diagnostic testing to evaluate your eligibility for the implant procedure.

All costs associated with this visit and the rest of your study participation will be covered by the study sponsor, even if you don’t choose to participate. If you complete the screening process and are found to be eligible for the study, your study site will schedule your implant procedure. The 60-90 minute procedure is performed while the patient is under general anesthesia by a surgeon with extensive experience in vagus nerve stimulation implant procedures.

 

What should I expect after the MicroRegulator is implanted to evaluate safety and effectiveness of vagus nerve stimulation for RA?

You typically return home a few hours after the procedure, and usually can resume activities of daily living the next day. A follow-up appointment will be scheduled with the surgeon for 14-21 days after the procedure.

MicroRegulator does not administer any drug into the body; rather, the device is designed to apply small electrical impulses to the vagus nerve for about one minute a day to activate the body’s natural immune response, which may treat RA (that’s what we’re investigating – vagus nerve stimulation for RA – in this study, thanks to patient participation!). Physicians use an iPad to individually program your MicroRegulator to turn on and deliver the therapy automatically every day, so there’s no need to remember to turn on the device.

The RESET-RA study has two phases. The first 12 weeks, or three months, is the “primary study,” during which you will be randomly assigned to either 1) the study treatment or 2) the control group, which does not receive the study treatment. After the primary study period ends, you can continue in the long-term phase of the study, during which all participants (including those who were in the control group) will receive the study treatment, and are also eligible to receive additional RA medications, including biologics or other DMARDs, as needed.

What this means is that you will receive the study treatment, but are not guaranteed to receive it in the first 12 weeks of the study. After implantation, you will have a 50/50 chance of being assigned to either control or treatment groups, but you will not be told your group assignment. (We have to have a control group, otherwise there would be no way to compare the new therapy to current treatments!)

Regardless of your group assignment during the first 12-week period, you will receive one minute of either active or non-active doses of stimulation each day and will be required to use your conventional DMARDs throughout the study. All participants will follow the same study procedures throughout their participation, including visiting the study site to program their device and complete various assessments, for a total of six visits over 12 weeks.

 

What happens after the 12-week primary study?

After 12 weeks, all participants – including those in the control group – can cross over to receive the study treatment and continue their participation in the long-term phase of the RESET-RA clinical trial for over three years. This means that you are now guaranteed to receive active doses of stimulation (study treatment) for the rest of the duration of the study. During this time, you will follow up with the rheumatology site every 12 weeks. Additionally, you will now be eligible to add other RA treatments into your regimen as needed.

You will receive payments for your time and travel during the course of the study. All costs of study-related procedures and assessments including implantation, programming, and removal (if needed) of the implant will be covered by the sponsor of the study.

About RA and existing treatment options

What should one consider when deciding whether to participate in a clinical study?

Why Participate in a Clinical Study

These viewpoints and experiences are from someone who participated in a prior SetPoint Medical study. Individual decision-making and experiences may vary.

What should one consider when deciding whether to participate in a clinical study?

Therapies approved today for Rheumatoid Arthritis (RA) have had to go through regulatory procedures, including clinical studies, before the FDA (US Food and Drug Administration) allows its commercial use. Those who participate in clinical studies have early access to an investigational therapeutic approach, as well as a dedicated study team focused on providing study participants with on-going, closely monitored healthcare.

Assessing New Options and Overcoming Barriers

People living with RA know the necessity of new treatment options as they are constantly balancing their symptom relief with the side effects and costs of the RA drugs. There is a significant need to ensure we are studying new treatment approaches that might improve upon today’s standard of care.

By participating in clinical research, you become a pioneer in the early days of a therapy that may have the potential to advance the future of treatment for the RA, and perhaps provide learnings for the broader patient community.

Unfortunately, clinical study enrollment across disease indications, including Rheumatoid Arthritis, is at an all-time low. While there are many factors to consider when deciding whether to participate in a clinical study, often, it’s fear of the unknown that may cause reluctance towards participating in a clinical study. This is completely natural – even when a treatment isn’t working, many may feel more comfortable and safer in the predictability of their current care routines rather than trying a new approach that is unknown and investigational.

“However, you can better evaluate your options by reviewing the science and understanding the details of the investigational approach being assessed in the clinical study.”

The reality for many people who suffer from RA, despite trying multiple medications, is that there are two options: one, to remain as is, with status quo of constant chronic pain, reliant on drugs that are expensive and often come with undesirable side effects, or the second option: to take a chance and try an entirely new, albeit investigational, treatment approach.

While the second option is investigational and there are no guarantees of benefits, a clinical study is your opportunity to be a pioneer in developing revolutionary treatment approaches.

Therefore, it is important to immerse yourself in learning as much as you can about the science and the mechanism of action of the new approach being studied in RESET-RA, and understand the potentials risks and benefits of participating in the clinical study.

How to enroll in a clinical study?

Those who participate in clinical research have an opportunity to experience patient care through a different lens while seeing firsthand the field of science and medicine converge. As a participant in research, it’s important to be fully informed on what your participation involves, what your role in the study entails, and then decide what’s best for you.

When applying to participate in a clinical study, you will hear a lot of terms that may be new to you, and these include:
 
Eligibility criteria: U.S. clinical studies for a new investigational therapy have a protocol that is approved by the FDA and IRB, and followed by the study’s research doctors, to evaluate an investigational therapy in a specific group of patients.
 
Clinical study protocol: This refers to the set of procedures to be followed by the investigators, study coordinators, and study participants. It includes a schedule of appointments and procedures, as well as guidelines for all involved to abide by to ensure that the study procedures are standardized, the safety of patients is protected, and that the effectiveness of the therapy being investigated is accurately evaluated.
 
Informed consent: This is a document that the study team will carefully go over with participants to ensure they understand exactly what they are signing up for if they choose to be in the study. This includes what will be expected of them (how many visits and when), any potential benefits and risks related to study participation, and so forth. It is important that you take your time to review this document and ask the study team any questions you may have before signing the informed consent form. The informed consent form is not a contract. Even after signing the informed consent, you can withdraw from the study at any time.
 
Rescue therapy: If your disease activity does not improve or worsens during the study, ‘rescue therapy’ may be given to help treat the symptoms or flare-up. The medications utilized as rescue therapy typically include therapies that are currently the standard of care and FDA approved, for example biologics or DMARDs that you may have already tried. Rescue therapy, therefore, gives your study doctor the option to intervene with all currently available treatments to help treat your RA, if needed. The RESET-RA study allows for rescue therapy for RA.
 
Control group (also called ‘placebo control’ or ‘sham arm’): Do not despair upon hearing this term! Before we discuss what this means, it’s important to highlight that in many studies, including the RESET-RA study, all patients receive the study treatment after reaching the three-month mark and can continue with the therapy for the rest of the study. With that preface out of the way, let’s talk about what a control group is and why it is important. If the clinical study is randomized, it includes what’s called a ‘control group’ and a ‘treatment group.’ The ‘treatment group’ gets the new investigational treatment being studied, and the ‘control group’ gets currently approved and available treatments pre-specified by the protocol. The reason it is important to include a ‘control group’ at the beginning is to ensure that the therapy being tested actually does something when measured against a group that is getting only the standard of care treatment, which, in the case of RESET-RA, is DMARDs. During the Informed Consent process mentioned above, the clinical study coordinator will discuss this with study participants.
 
Along with knowing these terms, it’s also important to know that your study costs are covered, and you can withdraw at any time, with no penalty. What’s more, participating in clinical studies doesn’t limit your typical care – in fact, while most people with a chronic illness check in with their specialists every three to six months, or perhaps only during periods of flare-ups, when participating in a clinical study, you have access to a dedicated clinical study coordinator with whom you can check in at any time. The clinical study coordinator is one of the best resources for you throughout the study – they will be someone you will rely on to get you in for appointments as needed, schedule your follow-ups, and answer any question you have about the study. 

Let’s say you’re ready to explore this new investigational option and find out if you can participate in the RESET-RA clinical study – where do you start? 

  1. Review the eligibility criteria and take the qualification questionnaire to see if you qualify.  
  2. If you do, you will be able to set-up a phone appointment with a health care professional who will review the eligibility criteria and answer questions about the study. They will also help you find a study center nearest to you and connect you to that center.
  3. You will then need to visit the study center in person and review the informed consent form with the site’s study coordinator – and if you so choose, sign the consent to start the process!
We appreciate you considering participation in the RESET-RA study.
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About Rheumatoid Arthritis (RA) and Existing Treatment Options

About Rheumatoid Arthritis (RA) and Existing Treatment Options

What is Rheumatoid Arthritis (RA)?

RA is a chronic autoimmune disease caused by excessive inflammation. The immune system typically uses inflammation in the body to attack infections caused by bacteria and viruses. But in autoimmune diseases like RA, the immune system is unbalanced, and inflammation attacks healthy tissue in the body which causes joint pain and swelling. Untreated RA can cause permanent damage to the joints, which can result in physical disability.

Existing RA Treatment Options

There is currently no cure for RA but medications known as disease-modifying antirheumatic drugs — referred to as DMARDs — can improve joint pain and swelling, improve comfort and function in day-to-day activities and slow the progression of joint damage.

There are multiple types of DMARDS – conventional synthetic, biologic and targeted synthetic.

Conventional synthetic DMARDs include:

  • Hydroxychloroquine (Plaquenil)
  • Leflunomide (Arava)
  • Methotrexate (Rheumatrex, Trexall, Otrexup, Rasuvo)
  • Sulfasalazine (Azulfidine)

If patients do not initially respond to or eventually stop responding to conventional DMARDs, a biologic DMARDs can provide additional treatment options.

Biologic DMARDs, or biologics, include:

  • Abatacept (Orencia)
  • Adalimumab (Humira)
  • Anakinra (Kineret)
  • Certolizumab (Cimzia)
  • Etanercept (Enbrel)
  • Golimumab (Simponi)
  • Infliximab (Remicade)
  • Rituximab (Rituxan, MabThera)
  • Sarilumab (Kevzara)
  • Tocilizumab (Actemra)

Targeted synthetic DMARDs for RA are primarily JAK inhibitors, and include:

  • Baricitinib (Olumiant)
  • Tofacitiniib (Xeljanz, Xeljanz XR)
  • Upadacitinib (Rinvoq)

Many RA patients are still not adequately treated with or are intolerant to biologics.1


1 Rheumatol Ther (2017) 4:489–502

These therapies can have serious side effects which is why the RESET-RA study is investigating a potential alternative, non-pharmaceutical option with vagus nerve stimulation therapy for patients who continue to experience symptoms of RA even after having tried multiple medications.