The Ultomiris Pregnancy Registry Study (NCT06312644), is sponsored by Alexion Pharmaceuticals, Inc. The Pregnancy Registry Study was created to collect information about the possible effects of ULTOMIRIS® on pregnancy, delivery, and the health of infants.
If you have a patient who wishes to learn more about the pregnancy registry study and agrees to be contacted by a study representative, please register their interest using the button below. Please ensure that all information you provide on behalf of your patient is HIPAA compliant.
Refer a patient View eligibility criteriaIf you have login details for the healthcare provider section of this website, please enter them below. You will receive login details when one of your patients is registered.
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The Ultomiris Pregnancy Registry Study was established to help determine pregnancy outcomes, frequency of maternal complications, and fetal and infant outcomes through the first year of life in infants of women who were exposed to ULTOMIRIS medication before and during pregnancy, as well as while breastfeeding.
Often, the effect of medications or treatments on pregnancy, or the health of an infant, is not known because pregnant women are usually excluded from research studies. It is hoped that this pregnancy registry study will help doctors to better understand if ULTOMIRIS has any effect on pregnancy, delivery, or the health of infants.
Information about this registry study is available at clincialtrials.gov (NCT06312644). You may also search for ULTOMIRIS on the US Food and Drug Administration (FDA) pregnancy exposure registries website.
Please call a study representative at +1-(833)-793-0563 for more information.
Your patient is potentially eligible to participate in this pregnancy registry study if she is/was pregnant, and:
As the HCP of a study participant, you may be contacted to provide updated medical records or information regarding your patient’s health at least once. Additional contacts may occur if necessary.
As the HCP of a participant’s infant, you may be contacted to provide updated medical records or information regarding the infant’s health at least once. Additional contacts may occur if necessary
At each contact point, you or your staff will be requested to answer questions about the participant’s health and pregnancy status or provide medical record information. Each call should take no longer than 10–15 minutes to complete.
If necessary, your patient will be asked to share information on her health, lifestyle, and pregnancy. She may be contacted:
At each time point, your patient will be asked to confirm her contact information.
You will not be compensated for your time. However, the information that you provide will help us learn more about the possible effects of ULTOMIRIS on pregnancy, delivery, and the health of infants whose mothers were exposed to ULTOMIRIS. It is hoped that the results of the pregnancy registry study will help you, your colleagues, and your patients make informed decisions about the use of ULTOMIRIS.
Women who join the Ultomiris Pregnancy Registry Study will provide a release of information form that will allow the North American Call Center (NACC) to contact their healthcare providers and provide medical records. These contacts are necessary to obtain information on the participant’s pregnancy and delivery, and/or the health of her infant.
The NACC will collect the information provided by the patient and the forms submitted by the healthcare providers. The data collected from all parties will be kept in a secure database as per our privacy policy. The patient’s health information will be kept anonymous and any identifying information will not be used.
Contact the North American Call Center at +1-(833)-793-0563 or UltomirisPregnancyRegistry@IQVIA.com for registration information
Assist your patient in filling out the contact form on the website or register your patient’s interest with their consent by clicking the link below
Inform your patient that she may enroll in the pregnancy registry study by calling +1-(833)-793-0563
For the latest Important Safety Information, please refer to the full Prescribing Information and Medication Guide. This is not meant to replace discussions with your doctor or healthcare provider.