FAQs

The Ultomiris Pregnancy Registry Study is sponsored by Alexion Pharmaceuticals Inc. It was created to help doctors better understand if ULTOMIRIS has any effect on pregnancy, delivery, or the health of babies. All women taking part in this pregnancy registry study will have been prescribed ULTOMIRIS.

Women can help by sharing their experiences throughout their pregnancy and information on the health of their babies until they are 1 year old.

You may be contacted by a study representative:

• when you join the pregnancy registry study,
• once during each trimester of your pregnancy and one month after estimated due date,
• when your baby is about 3, 6, and 12 months old, to find out about your baby’s health and breastfeeding (if applicable).
• If you are no longer pregnant when you join the Ultomiris Pregnancy Registry Study, the study representative may call once when you join as well as the listed timepoints until your baby is 12 months old.

Your doctor, your baby’s doctor, or other healthcare providers may also be contacted.

You will not be asked to attend extra visits at a healthcare provider’s office, or change anything you usually do. You also will not change any treatments that you currently receive for the duration of your participation in the pregnancy registry study.

If you would like further information to discuss with a family member, your regular doctor or other healthcare provider, or to share with others, you can download the Ultomiris Pregnancy Registry Study Patient Brochure.

This pregnancy registry study 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 pregnancy registry study with the participant’s rights and welfare in mind. An IRB has reviewed this study. The study representative will read and review the consent form (also reviewed by the IRB) with you. The form explains the study in detail and lets you know your rights. It also outlines your role as a participant in the study. You will receive a copy of the form.

The Ultomiris Pregnancy Registry Study will help doctors better understand if ULTOMIRIS has any effect on pregnancy, delivery, or the health of babies. Study representatives will collect information from people who took ULTOMIRIS for an approved condition during pregnancy.

By sharing your experience, you could help other women and their doctors to better understand if ULTOMIRIS has any effect on pregnancy, delivery, or the health of babies.

No. Participation in this pregnancy registry study 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 doctor or other healthcare provider.

Women with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD) who are pregnant or who were pregnant may be eligible. You must have received ULTOMIRIS before being pregnant, during pregnancy or while breastfeeding to join the pregnancy registry study. A study representative will confirm if you are able to take part.

After you decide that you want to join the Ultomiris Pregnancy Registry Study, you will give consent to access your previous medical records, and to allow us to contact you, your doctor and/or your baby’s doctor. You will then need to answer some 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 may be contacted by a study representative:

• when you join the pregnancy registry study,
• once during each trimester of your pregnancy and one month after estimated due date,
• when your baby is about 3, 6, and 12 months old, to find out about your baby’s health and breastfeeding (if applicable).
• If you are no longer pregnant when you join the Ultomiris Pregnancy Registry Study, the study representative may call once when you join as well as the listed timepoints until your baby is 12 months old.

If you join the pregnancy registry study, you will not need to make any extra visits to a doctor or healthcare provider. You will not be asked to change any current treatments during your time as a pregnancy registry study participant.

Your involvement with the pregnancy registry study will last for the duration of your pregnancy and until your baby is 1 year old.

Your initial telephone interview to provide consent may last about 45 minutes. The follow-up telephone calls that happen once per trimester and after your delivery will each last about 10–15 minutes.

There is no cost to you for joining the pregnancy registry study.

Please check with your mobile service provider about any charges that may be associated with receiving text messages.

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

Although it is a good idea to notify your doctor or other healthcare provider about your participation in the pregnancy registry study, their permission is not required.

If you agree to be in the study, you will give permission to your and your baby’s healthcare providers to share information about you and your baby.

We must collect your personal contact information to send you emails and call you to complete the telephone assessments. We will not store your personal contact information with your medical information. The researchers reviewing medical 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 ULTOMIRIS before, during, and after pregnancy while breastfeeding.

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 Alexion Pharmaceuticals Inc., the Sponsor of this pregnancy registry study. In any presentation of results from this pregnancy registry study, your identity will remain anonymous and confidential. The pregnancy registry study information is expected to be kept for 15 years, and may be kept longer.

Please contact a study representative at UltomirisPregnancyRegistry@IQVIA.com or use the registry study’s toll-free number +1-(833)-793-0563.

You can change your contact information at any time. Simply click the link in any of our emails to update your contact information. You can also contact the registry study team at UltomirisPregnancyRegistry@IQVIA.com or use the registry study’s toll-free number +1-(833)-793-0563.

Your participation in this pregnancy registry study is voluntary. You may withdraw your consent at any time. If you no longer want to participate, please contact us on the registry study’s toll-free number +1-(833)-793-0563

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

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