Overview

EPID Multiple Sclerosis Pregnancy Study

Status:
Completed
Trial end date:
2018-08-14
Target enrollment:
Participant gender:
Summary
Multiple Sclerosis (MS) is the most common chronic neurologic disability in young adult females in their childbearing ages. Little evidence is available regarding the association between exposure to IFN-beta (β) products and adverse pregnancy outcomes. Therefore the four marketing holders of IFN-β are conducting a European-wide IFN-β pregnancy registry. Additionally, the Committee for Medicinal Products for Human Use (CHMP) has requested a study to enable identification of pregnancy outcomes in the MS population unexposed to IFN-β products for comparison with the ongoing European IFN-β Pregnancy Registry.
Details
Lead Sponsor:
Bayer
Collaborators:
Biogen
EPID Research
Merck Serono Europe Ltd
Novartis Pharmaceuticals
Treatments:
Interferon beta-1a
Interferon beta-1b
Interferon-beta
Interferons