This research study is looking to enroll roughly 200 adults aged 18 and older who have been prescribed Vyvgart Hytrulo® (efgartigimod) to treat their Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) but have not yet started on the treatment. If you have already started taking your treatment with Vyvgart Hytrulo® you will not be eligible to take part in this study.
A real-world observational study is a type of research where scientists watch and record what happens to people in their everyday lives. These studies help us understand how treatments work in the real world in a wide variety of people and environments, providing valuable information for doctors and patients.
NOTE: You do not need to travel to take part in this study. Questionnaires can be completed from the comfort of your home, and study assessments can be done by tele-visit or by a nurse visiting you in your home. You will still continue to see your own doctor while taking part in the study.
People who take part in this real-world observation study will:
A virtual site means that there will not be a physical (brick & mortar) building for study visits. Rather, data will be collected “virtually.” So, those who may be eligible to enroll will be directed to a study-specific website in order to securely provide contact details. (The CRO or contract research organization will also provide detailed study information.)
Additionally, certain medical assessments may be performed remotely through video calls, in person at home by a visiting nurse or at their office (if preferred) to allow for flexibility.
Potential study enrollees will also be invited to provide their informed consent electronically to indicate that they agree to participate in the study. Those who meet the study criteria will be enrolled.
NOTE: As part of the consent process, if interested in enrolling, you will need to authorize access to your health-related data, including information from medical records and healthcare claims. Of course, a principal investigator (PI) will oversee all study operations.
CIDP is a rare type of autoimmune disease that affects the myelin sheaths (the coverings that protect the nerves) that results in inflammation that damages the nerves in the arms and legs. Though CIDP can occur in both men and women of any age, men in their 50s and 60s are more likely to develop the condition.
CIDP can get worse over time - especially if left untreated. Symptoms vary but can include muscle weakness and pain, numbness/tingling in the limbs, fatigue, loss of reflexes and issues with balance.
Vyvgart Hytrulo® has been licensed as a treatment for CIDP in adults in the US since June 2024. It is taken as an injection just under the skin and has been shown to be safe and effective for the treatment of autoimmune diseases like CIDP.
Although egartigimod has been studied extensively in CIPD clinical trials, very little information exists about how well it works for the treatment of CIDP in the real-world setting. The main purpose of this study is to gather information on how Vyvgart Hytrulo® is used and how it affects patients with CIDP in their everyday lives.
Specifically, researchers want to learn how well this treatment works from a patient’s point of view, what other treatments patients have tried, and overall, how satisfied patients are using the treatment.
Participation in this study lasts up to 2 years and 3 months with about 14 study visits. Visits can take place at the weekend as well as during the week and can also take place in the comfort of your own home. Everyone who takes part in this study will be monitored for approximately two years. You can withdraw from the study at any time and for any reason.
AcurianHealth helps connect people with research studies.
Since 1998, AcurianHealth has referred over 1 million study candidates to 800 research studies all over the world.
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