The answers to common questions that you may have about the registry are below. If you do not see the answer to your specific question here, please contact us at Genesispregnancyregistry@iqvia.com or use the registry’s toll-free number 1-(833)-244-4083.
This is a United States registry sponsored by Amgen Inc. for pregnant women diagnosed with migraine. Some women joining this registry will have taken Aimovig® (erenumab-aooe) shortly before or during pregnancy. Other women taking part will not have taken Aimovig or any medication targeting the calcitonin gene-related peptide (CGRP) pathway, including Ajovy® (fremanezumab-vfrm) and Emgality® (galcanezumab-gnlm). The purpose of this pregnancy registry is to learn more about the health of pregnant women who have taken Aimovig and the health of their babies, compared with those who have not taken Aimovig. 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 will be contacted by a registry representative when you join the registry, once each trimester, about 4 weeks after you have given birth, and when your baby is approximately 3 months, 6 months, and 1 year old. Your healthcare provider(s) will also be contacted 2 times during your pregnancy, and about 4 weeks after you deliver. Your baby’s healthcare provider will be contacted about 4 weeks after you have given birth, and when your baby is approximately 3 months, 6 months, and 1 year old. You will not be asked to attend extra visits at a healthcare provider’s office or change any treatments that you currently receive while you participate in the registry.
You can download a copy of the GENESIS Pregnancy Registry Patient Brochure if you would like to discuss the registry with others, like a family member or your doctor.
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 study. The consent form (also approved by the IRB) that the registry representative will read and review with you, explains the study in detail and lets you know your rights. It also outlines your role as a participant in the study. You will be provided with a copy of the consent form.
The GENESIS Pregnancy Registry has been set up to collect information from pregnant women who have taken Aimovig® (erenumab-aooe) shortly before or during pregnancy, and/or who are diagnosed with migraine. By sharing your experience, you could help doctors to better understand if Aimovig has any effect on pregnancy, delivery, or the baby for other women who may be taking it when they became pregnant.
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 diagnosed with migraine who are pregnant and have taken Aimovig® (erenumab-aooe) shortly before or at any time during pregnancy may be eligible. You may also join the registry if you have been diagnosed with migraine, are pregnant but have not taken Aimovig or any medication targeting the calcitonin gene-related peptide (CGRP) pathway, including Ajovy® (fremanezumab-vfrm) and Emgality® (galcanezumab-gnlm). 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 GENESIS Pregnancy Registry and give your written or electronic informed consent, you will need to answer some questions to see if you are eligible for participation. If you qualify, a registry representative will ask you some questions about yourself, your health, and your pregnancy.
A registry representative will contact you when you first consent to be a part of the registry, and then once during each trimester of your pregnancy. After you have given birth, you will be contacted about 4 weeks after your delivery, and when your baby is approximately 3 months, 6 months, and 1 year old. A registry representative will also contact your healthcare provider(s) after you consent to be part of the registry; 2 times during your pregnancy, and once about 4 weeks after your delivery. Your baby’s healthcare provider will be contacted about 4 weeks after your delivery, and when your baby is approximately 3 months, 6 months, and 1 year old. You will not be asked to attend extra visits at a healthcare provider’s office or change any treatments that you currently receive while you participate in the registry.
If you join this registry, your involvement will last for the duration of your pregnancy and until your baby is 1 year 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 per trimester and the four times after your delivery 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 study, 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 Aimovig® (erenumab-aooe) shortly before or 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 Amgen 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 15 years after the completion of the registry and may be kept for longer.
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)-244-4083.
Please contact your healthcare provider with any questions about your pregnancy.
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