Multiple Sclerosis (MS) Support Group
This community is a place where members can discuss current events and weigh in on what's going on in the world.
This community is a place where members can discuss current events and weigh in on what's going on in the world.
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Healthcare Professional Information
Rebif Pregnancy Registry
March 2005: We would like to inform you that Serono, Inc. and Pfizer Inc, comarketers
of Rebif (interferon beta-1a) for the treatment of relapsing forms of
multiple sclerosis (MS), are conducting a Pregnancy registry to determine the
safety of Rebif in women who are pregnant or who may become pregnant. The
FDA mandates these programs for many products due to the limited data on this
patient population obtained during premarketing clinical trials.
The Rebif Pregnancy Registry program will enroll women who are in the first
trimester of pregnancy and who were treated with Rebif within one week prior to
becoming pregnant or during pregnancy. The Rebif Pregnancy Registry collects
and assesses postmarketing data on outcomes of exposure to Rebif in pregnant
women with MS, their fetuses, and/or live born infants. These outcomes will be
compared to outcomes of a control group of women with MS who have not been
exposed to Rebif or any other interferon during pregnancy.
The program is designed to make it quick and convenient for you and your staff
to provide important information to MS patients who have been exposed
to/treated with Rebif during pregnancy. Investigator responsibilities include
obtaining informed consent, registering the patient, and providing pregnancy
outcome data. You will receive a reminder e-mail/fax within one month following
the anticipated due date.
Your participation and that of your patients is essential to developing and
completing the Rebif Pregnancy Registry and evaluating pregnancy outcomes.
We thank you in advance for your assistance.
How to enroll:
If a pregnant MS patient under your care may be eligible for enrollment in either
the Rebif arm or the control arm of the registry, please contact the Rebif
Pregnancy Registry at www.rebifpregnancyregistry.com or call, MS LifeLines at
1-877-44-REBIF (1-877-447-3243).
3/05