Here are answers to common questions that you may have about the registry. If you do not see the answer to your specific question here, feel free to contact us at firstname.lastname@example.org or use the registry’s toll-free number 1-(866)-810-1462.
This is a global registry for women with MS who are pregnant and have taken TECFIDERA. The purpose of this pregnancy registry is to learn more about the health of pregnant women who are taking or have taken TECFIDERA and the health of their babies. This will be done by monitoring participants throughout their pregnancy, followed by monitoring the health of their babies until they are 12 months old.
You will be contacted when you join the registry, and then once during each trimester. Your obstetrician and neurologist will also be contacted when you join, between the sixth and seventh month of your pregnancy, and approximately 4 weeks after your estimated delivery date. Your baby’s doctor will be contacted when your baby is 1, 3, and 12 months old. You will not be asked to attend extra visits at a doctor’s office, change anything you usually do, or change any treatments that you currently receive for the duration of your participation in the registry.
This registry is considered as a research study. For the protection of all participants, research studies are reviewed by an Institutional Review Board (IRB) who has approved this study. An IRB is a group of scientific and non-scientific individuals who perform the initial and ongoing ethical review of the registry with the participant’s rights and welfare in mind. The consent form that the registry representative will review with you outlines the study in detail and lets you know your role and rights as a participant in the study. You will be provided with a copy of the consent form.
The purpose of this pregnancy registry is to monitor how the use of TECFIDERA might affect women’s pregnancies and their babies. In the future, other pregnant women who are exposed to TECFIDERA may have more information as a result of this registry about how their pregnancies and babies may or may not be affected.
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 doctor.
Women with MS who are pregnant and have taken TECFIDERA since their last menstrual period, or who are currently taking TECFIDERA, may 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 registry and give your 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 some information about yourself, your health and your pregnancy, and will be contacted once during each trimester. The doctor who is caring for you during your pregnancy, and the doctor who prescribed you TECFIDERA, will also be contacted when you join, between the sixth and seventh month of your pregnancy, and within 4 weeks of your estimated delivery date. Your baby’s doctor will also be contacted when your baby is 1, 3, and 12 months old.
You will not be asked to attend extra visits at a doctor’s office, change anything you usually do, or change any treatments that you currently receive for the duration of your participation in the registry.
If you join this registry, then your involvement will last for the duration of your pregnancy, and until your baby is 12 months old.
Your initial telephone interview upon joining the registry may last for approximately 45 minutes. The follow-up telephone calls that will be made once per trimester will last approximately 10 minutes each.
There is no cost to you for joining the registry.
You will not be paid for taking part in the registry.
Although it is a good idea to notify your doctor about your participation in the registry, their permission is not required.
We must collect your personal contact information so that we can send you emails and call you to complete 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 TECFIDERA 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 Idec, the Sponsor of this registry. In any presentation of results from this registry, your identity will remain anonymous and confidential. The information will be deleted from the Quintiles database at completion of the registry.
For questions about the TECFIDERA Pregnancy Exposure Registry, please contact a registry representative at email@example.com or use the registry’s toll-free number 1-(866)-810-1462.
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 firstname.lastname@example.org, or use the registry’s toll-free number 1-(866)-810-1462.
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-(866)-810-1462.
Please contact your doctor with any questions about your pregnancy.
You will then be contacted by your local Registry Coordinating Center (RCC).
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