Enrollment in the VYVGART Pregnancy Study is entirely voluntary and may be initiated by healthcare providers or pregnant women themselves. All pregnant girls and women exposed to VYVGART any time within 25 days prior to conception or any time during pregnancy and/or breastfeeding are eligible.
To enroll a patient or to request additional information:
If a patient is eligible for participation, she will be asked to provide her informed consent to acknowledge her understanding and details about the study and provide permission to collect personal health information from healthcare providers involved in the care of her pregnancy and that of her infant.
Your patient's participation in the observational pregnancy study may last throughout her pregnancy and up to one year after her delivery date. Your patient will be contacted once per trimester, at the estimated date of delivery, and when her infant is 3, 6, 9, and 12 months of age to provide basic information about her pregnancy, post pregnancy health and her infant's health. At each timepoint your patient will be asked to confirm her contact information.
A healthcare provider's (HCP) participation will vary depending on if they are treating the patient or infant. The woman's obstetric HCP will be contacted between the 8th and 9th month of the patient's pregnancy and, again, within 4 weeks after the estimated delivery date. The pediatric HCP will be contacted when the baby is approximately 3, 6, 9, and 12 months old. In order to collect the information, the Pregnancy Study Coordinating Center will send questionnaires to the appropriate HCP for completion.
The Pregnancy Study Coordinating Center is responsible for collecting the study data. All data provided by you and/or your patient will be entered into the study database. The study database will be kept on a secure computer system maintained by the study administrator in accordance with their written security policy. Information about your patient's health collected while they are in the VYVGART Pregnancy Study will be kept anonymous and any identifying information will not be used.
The success of the VYVGART Pregnancy Study depends on the continued participation of healthcare providers like you. We greatly appreciate your help with identifying and enrolling patients in the study, and in assisting with the collection of follow-up information during your patient's participation in the study.
As a general reminder, for patients not
participating in the registry, any side effects experienced in association with the use
of
VYVGART, should be reported to
argenx PV group at
reportnow@argenx.com
or call
1-833-274-9411
or FDA at https://www.accessdata.fda.gov/scripts/medwatch/
