Eligible patients will be invited to take part in an investigational medical device study that is testing a possible new treatment for rheumatoid arthritis.
Up to 28 participants, diagnosed with rheumatoid arthritis, will be enrolled in The ConsideRAte Study held at clinical research centers located throughout the United States and the Netherlands.
The study will include 14-27 visits to a research center near your home. Depending on your potential treatment benefits and your body's response to the study device, the study is expected to last between 22-58 weeks. Participants in the study will also be enrolled in a 5 year long-term follow-up period.
There is no cost to take part in The ConsideRAte Study, and you do not need insurance to participate in the study. In addition, participants will receive all study-related care from a dedicated medical team at no cost. Those who take part in the study will receive $50 per visit and $300 after the implant procedure visit. If you are required to stay overnight for a visit, reimbursement for your costs (such as accommodation and meals) will be available.
You may be eligible for The ConsideRAte Study if you:
- Are 22 to 75 years old
- Have had a diagnosis of rheumatoid arthritis for at least 6 months
- Have taken multiple medications for rheumatoid arthritis but are not seeing improvement of your symptoms
There is no cost to participate in the study. All study-related care, including the medical device, will be provided at no cost. Those who take part in the study will receive compensation approximately $50 per visit and $300 after the implant procedure. If you are required to stay overnight for a visit, reimbursement for your costs (such as accommodation and meals) will be available.
Caution: Investigational device. Limited by United States law to investigational use.
Sign Up
What happens if I sign up? We will match you to a study location in your area that is participating in The ConsideRAte Study or notify you when one becomes available. The study team will then contact you and you may have the opportunity to participate in the study if you are eligible.
If you think you might like to participate in The ConsideRAte Study or would like more information, please enter your information below so we can see if you may be eligible and can contact you about the study. Participation is entirely voluntary. If you do decide to take part in the study, you may change your mind at any time.
About Rheumatoid Arthritis
Rheumatoid arthritis, or RA, is a lifelong, autoimmune disease in which the body’s immune system mistakenly attacks the body’s own tissues, typically the soft tissue lining the joints, leading to joint inflammation, pain, and stiffness. Over time this inflammation can cause tissue damage, deformity and disability.
Rheumatoid arthritis will usually affect multiple joints, most commonly those of the hands and feet. However, as the disease progresses, it can spread to the wrists, knees, ankles, hips, and shoulders.
Typical symptoms of rheumatoid arthritis include:
- Joint pain, tenderness, and swelling in more than one joint
- Joint stiffness (especially in the morning)
- Systemic symptoms such as myalgia, fatigue, fever, weight loss and depression1
- Joint deformity
- Redness or inflammation
Risk factors of rheumatoid arthritis:
- Age 60 years or above
- Are female or have never given birth
- Genetic traits
- Obesity
- Tobacco usage
Although the exact cause remains relatively unknown, a physician can diagnose rheumatoid arthritis by conducting bloodwork findings, clinical evaluations, and medical imaging such as x-rays.1 Once diagnosed, several different treatment options may be available such as DMARDs (Disease Modifying Anti-Rheumatic Drugs), which partially “turn-off” the body’s immune system. Pain medication may be recommended to help manage the discomfort and inflammation.
The ConsideRAte Study is a medical device clinical study that is testing a possible new treatment for rheumatoid arthritis. This study will evaluate the safety, tolerability, and effects of stimulating the splenic nerve through an implanted device system, similar to a pacemaker.
Frequently Asked Questions
What is a research study?
A research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational treatment – these may include how well the investigational treatment works for a certain condition. All medications and medical devices must be tested in clinical research studies before they can be approved and prescribed to patients.
Why are research studies important?
A research study is the process by which new and innovative medications, interventions, and treatments are approved and brought to patients, so people can live happier and healthier lives. Even over-the-counter medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), you may have used to counteract a headache, have gone through the clinical research study process before it was available at your local pharmacy.
What is the purpose of The ConsideRAte Study?
The ConsideRAte Study is a medical device clinical study that is testing a possible new treatment for rheumatoid arthritis. This study will evaluate the safety, tolerability, and effects of stimulating the splenic nerve using a laparoscopically implanted device system, similar to a pacemaker.
What will The ConsideRAte Study involve?
The ConsideRAte Study will enroll about 28 participants diagnosed with rheumatoid arthritis. The study will include 14-27 visits to a research center near your home. Depending on your potential treatment benefits and your body's response to the study device, the study is expected to last between 22-58 weeks. Participants in the study will also be enrolled in a 5 year long-term follow-up period.
This study involves laparoscopically implanting an investigational medical device, which is approximately the size of a house key. This device stimulates the splenic nerve using technology similar to a pacemaker.
Will I receive compensation?
Participants will be compensated for their time and travel required to take part in this study. Participants will receive approximately $50 per visit and $300 for the implant procedure.
Is there a cost to participate?
There is no cost to participate in The ConsideRAte Study and you you do not need health insurance to participate in the study. If you are eligible, all study-related care, including the investigational medical device will be provided at no cost.
What else do I need to consider?
The research team will be able to explain more about what The ConsideRAte Study will involve. Participation in this study is entirely voluntary and it is up to you to decide if you want to take part. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
How far is the research center?
We will match you to a research center within a close travel distance from your home. If we are not currently running the study in your area, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decide you no longer want your information stored, you can opt out and we will delete your details.
About The ConsideRAte Study
Up to 28 participants, diagnosed with rheumatoid arthritis, will be enrolled in the ConsideRAte Study held at clinical research centers located throughout the United States and the Netherlands.
The study will include 14-27 visits to a research center near your home. Depending on your potential treatment benefits and your body's response to the study device, the study is expected to last between 22-58 weeks. Participants in the study will also be enrolled in a 5 year long-term follow-up period.
There is no cost to take part in the ConsideRAte Study and you do not need health insurance to participate in the study. In addition, participants will receive all study-related care from a dedicated medical team at no cost. Those who take part in the study will receive approximately $50 per visit, and $300 after the implant procedure. If you require an overnight stay for a visit, further reimbursement is available.
Who can take part in the ConsideRAte Study?
You may be eligible for the ConsideRAte Study if you:
- Are 22 to 75 years old
- Have had a diagnosis of rheumatoid arthritis for at least 6 months
- Have taken multiple medications for rheumatoid arthritis but are not seeing improvement of your symptoms
ConsideRAte Study is investigating a new treatment for RA using an implanted investigational medical device to stimulate the splenic nerve to potentially reduce inflammation and symptoms of RA. The implanted investigational medical device is approximately the size of a house key and generates stimulation, similar to a pacemaker.
Caution: Investigational device. Limited by United States law to investigational use.
