This information is intended for U.S. residents only.
What is NaVYVgate?
NaVYVgate is an observational, post-approval safety study in adult patients who have been diagnosed with generalized myasthenia gravis (gMG). The study is open for patients who will be treated with efgartigimod alfa* or other gMG medication. Approximately 680 patients with gMG from both Europe and United States will be enrolled in this study. Those who take part will also continue to receive their usual treatment from their doctor.
Why participate in the study?
During the study, information collected will help doctors better understand how different treatments affect people diagnosed with gMG. The study will look at the long-term safety in patients treated with efgartigimod alfa compared to those not treated with efgartigimod alfa.
What is an Informed Consent Form (ICF)?
The Informed Consent Form describes the study and how data may be shared for study purposes. By signing this form, you are agreeing to participate. Please read the form carefully and, if there is something you do not understand, ask the study doctor or a team member.
Participation in this study is entirely voluntary. If you sign up and decide you no longer want to take part, you can stop at any time. Just speak with your doctor. Withdrawal of consent will not affect your treatment or care.
What will patients be required to do?
By agreeing to take part in the study, patients will:
- Receive their usual treatment for gMG as prescribed by their doctor - no special medication or study visits will be required
- Attend their medical appointments as usual
- Complete a patient/physician contact form and sign an Informed Consent form
Study Objectives
Primary Objective
- To evaluate the overall long-term safety of efgartigimod alfa including the occurrence of serious infections in gMG patients treated with efgartigimod alfa compared to gMG patients not exposed to efgartigimod alfa.
Exploratory Objectives
- To evaluate the safety of efgartigimod alfa in immunocompromised patients
- To evaluate the safety of efgartigimod alfa administered to patients treated with monoclonal antibodies
- To evaluate the safety of efgartigimod alfa in patients receiving live/attenuated vaccine
- To evaluate the safety of efgartigimod alfa in patients with severe renal impairment
Will my privacy be protected?
The doctor and their staff will respect the privacy of all patients who take part. All personal and medical information will be kept strictly confidential. For further information about privacy, please speak to your doctor and review the Informed Consent form.
Who can participate?
Patients can participate if they:
- Are 18 years of age or older and diagnosed with gMG
- Agree to participate in this study by signing the study Informed Consent Form
Prescribing Information
An Observational Study of Adult Patients with Generalized Myasthenia Gravis (gMG)
Attention: Protocol ARGX-113-PASS-2208 is your primary source of information regarding the conduct of the study and the assessment and reporting of adverse events and serious adverse events. Study protocol information is available at Study Details page.
If you are a participating prescriber and have questions about the study, please contact your local Clinical Research Associate (CRA) or Clinical Trial Specialist (CTS).
