FAQs

This is a global registry for women with MS who are 18 years or older, pregnant, and have or have not received OCREVUS^® (ocrelizumab). The purpose of this pregnancy registry is to learn more about the health of pregnant women who have received ocrelizumab and the health of their babies, compared with those who have not. This will be done by monitoring participants throughout their pregnancy, then monitoring the health of their babies until they are at least 12 months old.

You will be contacted when you join the registry, and then once during each trimester of your pregnancy. After you have given birth, you will be contacted when your baby is 1, 3, 6, and 12 months old. Your healthcare providers will also be contacted twice during your pregnancy, and approximately 4 weeks after your estimated delivery date. Your baby’s healthcare provider will be contacted when your baby is 1, 3, 6, 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 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 ocrelizumab might affect women’s pregnancies and their babies. Because of this registry, other pregnant women who are exposed to ocrelizumab in the future may have more information 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 healthcare provider.

Women with MS who are pregnant and have received ocrelizumab at any time since 6 months before their last menstrual period, or who are currently receiving ocrelizumab, may be eligible. You may also join the registry if you have MS, are pregnant and have not received ocrelizumab or any other MS disease-modifying therapy, with exception of glatiramer acetate, at any time since 6 months before your last menstrual period. You can only join the registry if you are 18 years or older. 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 of your pregnancy. After you have given birth, you will be contacted when your baby is 1, 3, 6, and 12 months old. Your healthcare providers will also be contacted twice during your pregnancy, and within 4 weeks of your estimated delivery date. Your baby’s healthcare provider will be contacted when your baby is 1, 3, 6, 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 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 at least 12 months old.

Your initial telephone interview upon joining the registry may last 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. You may be compensated if you agree to take part in the communications program (where you will receive reminders and information per email or text messages); however, this is subject to local regulations and it may not be available at your location.

Although it is a good idea to notify your healthcare provider 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 ocrelizumab 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 F. Hoffman-La Roche Ltd, 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 IQVIA database at completion of the registry.

For questions about the OCREVUS Pregnancy Registry, please contact a registry representative at ocrevuspregnancyregistry@iqvia.com or use the registry’s toll-free number 1 (833) 872-4370.

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 ocrevuspregnancyregistry@iqvia.com or use the registry’s toll-free number 1 (833) 872-4370.

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) 872-4370.

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.