The VYVGART
Pregnancy Study
Welcome to the VYVGART Pregnancy Study
The VYVGART Pregnancy Study was created by argenx BV, the manufacturer of VYVGART® (efgartigimod alfa-fcab) and VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc)*.
The purpose of this pregnancy study is to collect safety information on pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy, and to follow the outcomes of those pregnancies. Women exposed to efgartigimod during breastfeeding will also be eligible for this pregnancy study.
argenx BV has partnered with United BioSource LLC (UBC) (https://ubc.com) to help facilitate the VYVGART Pregnancy Safety Study. UBC will only collect and use relevant personal information on behalf of argenx BV as a data processor. UBC cannot use any personal information for its own purposes, as argenx BV maintains its role as a Sponsor of the study and responsible data controller.
Your participation in this study will help argenx BV to determine if there are any unknown safety risks of efgartigimod in pregnant women or their babies if exposed to efgartigimod during pregnancy and/or breastfeeding. The study data will be provided to regulatory agencies and healthcare providers treating women with efgartigimod to better understand any possible adverse events of efgartigimod use on pregnant women and their babies.
*The pregnancy safety study is open to pregnant/breastfeeding women who have received either VYVGART (efgartigimod alfa-fcab) or VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) - referred to as “efgartigimod” or “VYVGART” interchangeably throughout this site and study documents.
Welcome to the VYVGART Pregnancy Study
The VYVGART Pregnancy Study was set up by argenx BV, the manufacturer of VYVGART® (efgartigimod alfa). The purpose of this observational pregnancy safety study is to collect valuable safety information on pregnant women and/or breastfeeding women and their babies exposed to efgartigimod. An observational study means you will continue to receive medical care as decided by you and your doctor(s). You will not be asked to do any additional procedures or tests for this study.
This study will help argenx BV to learn if taking efgartigimod during pregnancy and/or breastfeeding affects pregnant women or their babies. The collected study data will be shared with health agencies and doctors. This may help other women better understand any possible effects of efgartigimod on pregnant women and their babies.
argenx BV has partnered with United BioSource LLC (UBC) to support the VYVGART Pregnancy Study. UBC will only collect and use relevant personal information on behalf of argenx BV as a data processor. UBC cannot use any personal information for its own purposes, as argenx BV maintains its role as a Sponsor of the study and responsible data controller.
Find Out More and Enroll
You are eligible to participate if you meet either of the requirements listed below:
A
You have been treated with efgartigimod any time during your pregnancy or have been treated with efgartigimod within 25 days prior to becoming pregnant;
or
B
You have been treated with efgartigimod while breastfeeding a child
Within United States: Call
1-855-272-6524
Hours of operation:
Monday - Friday
8:00 a.m. to 5:00 p.m. Eastern Time
Email:
Vyvgartpregnancy@ubc.com
Live outside the US?
If you do not see your country on this website, email us at
Vyvgartpregnancy@ubc.com
to find out if you are eligible for this study.
Notify your healthcare provider right away if you become pregnant or plan to become pregnant while on efgartigimod.
For more information please visit
To learn more about the study:
- Please contact your doctor
- Contact one of the participating doctors listed below for more information about the study
or
Germany
Telephone: [+49 234 509-3923]
Email: [mg.kinderwunsch@klinikum-bochum.de]
Italy
Telephone [+39 0630154155]
Email: [raffaele.iorio@policlinicogemelli.it]
Spain
Telephone: [+34 671 69 8497 (pager)]
Email: [raul.juntas@vallhebron.cat]
Notify your doctor right away if you become pregnant or plan to become pregnant while on efgartigimod.
If you are a physician interested in the registry or you want to enrol a patient, please go to
"More Information for Healthcare Providers"
