The OCREVUS Pregnancy Registry is a global observational registry of women 18 years or older with MS who are pregnant and have received OCREVUS® (ocrelizumab). This registry commenced in 2019. The goal is to enroll 290 ocrelizumab-exposed women, to observe 153 pregnancy outcomes. In addition, the internal comparator group will enroll approximately 290 pregnant women to support the study objective to compare the outcomes of the ocrelizumab-exposed women with the outcomes of non-exposed women.
Internal comparator patients will be enrolled from the same sites as the ocrelizumab-exposed women and follow the same study procedures for follow-up and data collection. The internal comparator group will consist of currently pregnant women with MS who were not exposed to any MS DMTs during the 6 months prior to their LMP or at any time during pregnancy (apart from glatiramer acetate [e.g. Copaxone®] exposure through the first trimester).
It is hoped that this registry will help healthcare professionals to better understand if OCREVUS® has any effect on pregnancy, delivery, or the health of infants, since women may have taken OCREVUS® before realizing they were pregnant.
The OCREVUS Pregnancy Registry is listed on the US Food and Drug Administration (FDA) pregnancy exposure registries website.
Please call a registry representative at
1-(833)-872-4370 for more information.
Your patient is potentially eligible to participate in this registry if she is 18 years or older and pregnant, has MS, and:
As the HCP of a study participant, you will be contacted:
As the HCP of a participant’s infant, you will be contacted when the infant is about:
At each contact point, you or your staff will be requested to:
The worksheets should take no more than 10–15 minutes to complete. The information requested will be obtained from your patient’s medical record.
If your patient consents and is eligible to take part, she will be asked to share information about herself, her health and her pregnancy, and will be contacted:
At each time point, your patient will be asked to confirm her contact information.
You may be compensated for the time you spend on providing the information. The information that you provide will help us learn more about the possible effects of OCREVUS on pregnancy, delivery, and the health of infants whose mothers were exposed to OCREVUS during pregnancy. In the future, it is hoped that the results of the registry will help you and your colleagues, along with your patients, make more informed decisions about the use of OCREVUS.
Women who join the OCREVUS Pregnancy Registry will provide a release of information form that will allow the Registry Coordinating Center to contact their healthcare providers. These contacts are necessary to obtain information on the participant’s pregnancy and delivery, and/or the health of their infant.
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