The Maternal and Postnatal Outcomes Study (MOS)
MOS is evaluating the safety of Elfabrio® in individuals with Fabry disease during pregnancy and while breastfeeding. Help your patients enroll online for the MOS pregnancy registry.
There are no study visits.
All interactions are by phone or online.
Explain to your patients that the purpose of the MOS pregnancy registry is to create a worldwide information source, called a pregnancy registry. Once established, the MOS pregnancy registry will help you (the healthcare provider) learn more about the effects of Elfabrio® (pegunigalsidase alfa-iwxj) on your patients with Fabry disease during pregnancy and/or while breastfeeding.
Tell your patients that there are a few requirements to qualify for the MOS pregnancy registry. Being pregnant, having been pregnant, and/or breastfeeding while taking Elfabrio® (pegunigalsidase alfa-iwxj) for Fabry disease are the basic requirements for participation.
No study visits are needed to be part of the MOS pregnancy registry. If your patient qualifies, they are then asked to sign an informed consent form (like any other clinical trial). Then, you and your patients will be given access to a web-based platform to take part in the registry and record information each trimester during pregnancy, at the end of the pregnancy, and every 3 months until the baby turns 1 year. Explain to your patients that the MOS pregnancy registry mostly involves answering questions on the MOS website, providing information about:
- Fabry disease and treatment history
- Pregnancy
- Problems that your patient may have during pregnancy
- Breastfeeding
- Baby’s date of birth
- Baby’s birth weight
- Baby’s health during the first year
Find out if your
patient can participate.
If your patient prequalifies (by answering the prescreener questions online), they will be contacted by a member of the study team for further screening with additional questions about their pregnancy, Fabry disease, Elfabrio® (pegunigalsidase alfa-iwxj), and the health of the baby.
Have an informative discussion with your patient about the role of pregnancy registries. Explain that there are many medications to treat medical conditions that continue to provide benefit to individuals while pregnant, but the effects of those medications on the pregnancy and developing baby are not fully known. A pregnancy registry is a type of research study designed to create a database (collection of information) that helps doctors and other healthcare providers better understand if a certain medication has any effect on pregnancy and the developing baby.
Pregnancy registry studies collect information during pregnancy, and depending on their design, may continue to ask patients about childbirth and the baby’s health during the newborn period and/or while breastfeeding. The ultimate purpose of a pregnancy registry is to help other individuals with the same condition and their doctors know what to expect while taking a certain medicine during pregnancy and/or breastfeeding so that the condition can still be treated while pregnant/breastfeeding.
Frequently asked questions
Explain to your patient that taking part in this study is entirely voluntary. It is up to your patient to decide whether to take part in the study or not. If your patient decides to agree to take part, your patient will be asked to sign and date the informed consent form electronically in the registry web-based platform. Alternatively, your patient can also provide verbal consent to participate in the study. Your patient will receive a confirmation e-mail for their records.
Your patient may opt out of participation at any time without giving any reason even if she agreed earlier.
If your patient decides against taking part, your patient will not receive any penalties or result in any loss of benefits. Reassure your patient that you will continue be the treating physician with the most appropriate therapy for her condition.
All information collected about your patient and her child during the course of the study will be kept strictly confidential.
By signing the consent form and taking part in this study, your patient agrees for the clinical research organization (CRO) and Study Center (if applicable) to collect and process her (and her child’s) personal information and agrees for Chiesi Farmaceutici S.p.A., who is the Sponsor for this study, to use her and her child’s personal data for the study, to learn about the study drug (Elfabrio®), to help with study drug approval by health authorities, and to support future research and to improve science.
Please explain to your patient that providing her (and her child’s) personal data is needed in order to verify if she can take part and to include her in the study. Refusal to give consent to process her and her child’s personal data will mean that she cannot join the study.
Elfabrio® (pegunigalsidase alfa-iwxj) is a medication approved for the treatment of Fabry disease. The MOS pregnancy registry will collect information about the safety of Elfabrio® during pregnancy and/or while breastfeeding. Knowing this information will help individuals in the future make informed decisions when they become pregnant so that treatment for Fabry disease can continue without harming the pregnancy or developing baby.
Participation in any pregnancy registry is completely voluntary. Your patient’s decision to participate—or not participate—in this registry will have no effect on the medical care that they receive now or in the future. If your patient is eligible and chooses to participate in the registry, they may withdraw from the registry at any time.
Your patient may receive financial compensation for their time as part of their participation in this study. The specific amount and details of this compensation will be explained to your patient prior to their participation.
Your patient will first be asked some general questions (here) that help us determine whether your patient meets the basic criteria of the registry. If your patient does meet these criteria, they will be contacted to see if they fit the specific qualifications for the registry.
Every pregnancy registry must be reviewed, and is continually monitored, by an ethics committee to ensure the risks are as low as possible and do not outweigh any potential benefits to the study participant. As a volunteer, your patient has the right to discontinue participation and leave the registry at any time, with no penalty or loss of benefits to which she is otherwise entitled.
Chiesi, the maker of Elfabrio® (pegunigalsidase alfa-iwxj), is responsible for conducting this pregnancy registry.
