FAQs

This is a global registry for women with NMOSD who are or have been pregnant, and have received ENSPRYNG^® (satralizumab). This is defined as taking satralizumab within the 6 months before getting pregnant or at any time during pregnancy. The purpose of this pregnancy registry is to learn more about the health of pregnant women who have received satralizumab and the health of their babies. This will be done by monitoring participants throughout their pregnancy, and then monitoring the health of their babies during the first year of their life.

You will be contacted when you join the registry and then once during each trimester of your pregnancy. After you give birth, you will be contacted when your baby is 1, 3, 6, and 12 months old. Your healthcare provider(s) will also be contacted twice during your pregnancy, and 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.

Women can help provide more information about satralizumab and pregnancy by sharing their experiences throughout their pregnancy and information on the health of their babies during the first year of life.

If you would like further information to discuss with a family member or your regular doctor, you can talk to a study doctor or a member of the study team designated by the study doctor at the coordinating center by calling 1 (833) 277-9338.

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 participants’ rights and welfare in mind. An IRB has approved this study. The consent form (also approved by the IRB), which the study doctor or member of the study team designated by the study doctor 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. Participants younger than 18 years of age who are or were pregnant may be able to take part in the registry. Parents or legal guardians of minor participants will provide consent on their behalf and minors will provide an assent. In addition, after the birth of the baby, the father or legally authorized representative of the baby will also need to provide consent to collect health information about the baby.

The purpose of this pregnancy registry is to monitor how the use of satralizumab might affect women’s pregnancies and their babies. Because of this registry, other pregnant women who are exposed to satralizumab 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. Participation in the registry will not affect routine care you receive.

Women with NMOSD who are or have been pregnant and have received satralizumab in the 6 months before getting pregnant or during pregnancy may be eligible. Your eligibility for participation will be confirmed by the coordinating center before you join the registry.

If you decide that you want to join the ENSPRYNG Pregnancy Registry and give your verbal or written 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 additional information about yourself, your health, and your pregnancy. You will be contacted when you first consent to be a part of the registry, and then once during each trimester of your pregnancy. After you give birth, you will be contacted about 4 weeks after your estimated delivery date and when your baby is 3, 6, and 12 months old. Your healthcare provider(s) will also be contacted if you consent to be part of the registry, twice during your pregnancy, and within 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.

If you join this registry, your involvement will last for the duration of your pregnancy and until your baby is at least 12 months old (21 months in total).

Your initial contact with the coordinating center upon consenting for the registry is estimated to last about 45 minutes. The follow-up contacts that will be made once per trimester and after your delivery is estimated to last about 10–15 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 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.

The coordinating center must collect your personal contact information so that they can reach out to you to see if you want to take part. Your contact information will also be needed so that you can complete the telephone assessments. Your personal contact information will be stored by the coordinating center but will not be shared with the sponsor or with any other third parties. It will be stored separately from your medical information. This means that researchers reviewing the data about your pregnancy will not have access to your personal contact information.

We will use your information for research purposes. We will collect information about your identity, your health, and the health of your baby. The information you provide may help researchers gain insight into the use of satralizumab during pregnancy.

The information you provide to the coordinating center 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. Hoffmann-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 by the coordinating center at completion of the registry.

For questions about the ENSPRYNG Pregnancy Registry, please contact the coordinating center study doctor:
Email address: NMOSDPregnancy@jefferson.edu
Phone number: 1 (833) 277-9338.

You can change your contact information at any time. Simply contact the registry team at
Email address: NMOSDPregnancy@jefferson.edu
Phone number: 1 (833) 277-9338.

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 the coordinating center at 1 (833) 277-9338.