FAQs

The BlossoMS Pregnancy Registry is sponsored by Biogen Inc. It was created to help doctors better understand if Vumerity^® (diroximel fumarate) has any effect on pregnancy, delivery, or the health of babies. Women taking part in this registry will be pregnant and have MS. In addition, they will either have been prescribed diroximel fumarate and became pregnant while taking it, or they will not have had any MS therapy during pregnancy.

Women can contribute by allowing their experiences to be shared throughout their pregnancy and allowing information on the health of their babies to be collected until their babies are 12 months old.

You will be contacted by a registry representative when you join the registry, and then once during each trimester of your pregnancy. Your healthcare providers will also be contacted when you enroll, once during your pregnancy, and after you deliver. Your baby’s healthcare provider will be contacted when your baby is 1, 3 and 12 months old. You will not be asked to attend extra visits at a healthcare provider’s office, change anything you usually do, or change any medications that you currently receive for the duration of your participation in the registry.

If you would like further information to discuss with a family member or your regular doctor, or to share with others, you can download a copy of the BlossoMS Pregnancy Registry Patient Brochure.

This registry is a research study. For the protection of all participants, research studies are reviewed by an Institutional Review Board (IRB). An IRB is a group of scientific and non-scientific individuals who perform an ongoing ethical review of the registry with the participant’s rights and welfare in mind. An IRB has approved this registry. The consent form (also approved by the IRB) that the registry representative will read and review with you, explains the registry in detail and lets you know your rights. It also outlines your role as a participant in the registry. You will be provided with a copy of the consent form.

The BlossoMS Pregnancy Registry was created to help doctors better understand if Vumerity^® (diroximel fumarate) has any effect on pregnancy, delivery, or the health of babies. Registry representatives will collect information from pregnant women with multiple sclerosis who have taken diroximel fumarate, or no MS therapy, during pregnancy. Your contribution could help other women and their doctors to better understand if diroximel fumarate has any effect on pregnancy, delivery, or the health of babies. It is not known whether diroximel fumarate will harm unborn babies.

No. Participation in this registry does not offer direct access to any medical services or advice. It also does not endorse or provide any healthcare product or service. If you have any questions about your healthcare, please talk to your healthcare provider.

Women with MS who are pregnant and have received Vumerity^® (diroximel fumarate ) at any time during pregnancy may be eligible. Women with MS who are pregnant and have not had any MS therapy may also be eligible. Your eligibility for participation will be confirmed by a registry representative before you join the registry.

After you decide that you want to join the BlossoMS Pregnancy Registry and give your verbal informed consent, you will need to answer a few questions to see if you are eligible for participation.

If you are eligible to take part, you will be asked to provide additional information about yourself, your health, and your pregnancy. You will also give permission for your and your baby’s healthcare providers to do the same. You will be contacted when you first consent to be a part of the registry, and then once during each trimester of your pregnancy. You may also be contacted if your or your baby’s healthcare providers are not able to be reached. Your healthcare providers will also be contacted after you consent to be part of the registry, once during your pregnancy, and after your delivery. Your baby’s healthcare provider will be contacted when your baby is 1, 3 and 12 months old. You will not be asked to attend extra visits at a healthcare provider’s office, change anything you usually do, or change any medications that you currently receive for the duration of your participation in the registry.

If you join this registry, information about you and your baby will be collected until your baby is 12 months old.

Your initial telephone interview upon consenting for the registry may last approximately 45 minutes. The follow-up telephone calls that will be made once each trimester will last approximately 10–15 minutes each.

There is no cost to you for joining the registry. Please check with your service provider about any charges that may be associated with receiving text messages if you decide you want to receive text message reminders from the registry team.

You will not be paid for taking part in the registry.

Although it is a good idea to notify your healthcare provider about your participation in the registry, their permission is not required. As part of your agreement to be in the registry, you will give your and your baby’s healthcare providers permission to share information about you and your baby.

We must collect your personal contact information so that we can send you emails and call you to complete the telephone assessments. Your personal contact information will be stored separately from your medical information. This means that researchers reviewing the data will not have access to your personal contact information.

We will use your information for research purposes. We will collect information about your identity, health, and the health of your baby. The information you provide may help researchers gain insight into the use of Vumerity^® (diroximel fumarate) during pregnancy.

The information you provide in telephone interviews will not be associated with your name, your baby’s name, or your contact details. Your personally identifying information will not be shared with Biogen Inc., the sponsor of this registry. In any presentation of results from this registry, your identity will remain anonymous and confidential. The information is expected to be kept for 25 years after the completion of the registry, and may be kept longer.

For questions about the BlossoMS Pregnancy Registry, please contact a registry representative at BlossoMSPregnancyRegistry@IQVIA.com or use the registry’s toll-free number 1-(833)-569-2635.

You can change your contact information at any time. Simply click the link in any of our emails to update your contact information, contact the registry team at BlossoMSPregnancyRegistry@IQVIA.com, or use the registry’s toll-free number 1-(833)-569-2635.

Your participation in this registry is voluntary; you may withdraw your consent at any time. If you decide you no longer want to participate, please contact us on the registry’s toll-free number 1-(833)-569-2635.

To learn more about our Privacy Policy and how your information will be used, please visit our Privacy Policy page.

Please contact your healthcare provider with any questions about your pregnancy.