Multiple Sclerosis Clinical Trial
Official title:
Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon β - a Register-based Study in the Nordic Countries
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.
Information will be obtained from the Drugs and Pregnancy Project database (DPP - FIN) and
the Medical Birth Register (MBR - SWE, NOR). The Finnish DPP and Norwegian MBR include
information on all stillbirths of foetuses with a birth weight of at least 500 g or with a
gestational age of at least 22+0 Gestational Week (GW). The Swedish MBR includes data on
stillbirths after 28 GW
The estimated number of pregnancies in MS patients needed is 1671, encompassing data from:
i) FIN: 1 January 1996 - 31 December 2014; ii) SWE: 1 July 2005 - 31 December 2014; iii) NOR:
1 January 2004 - 31 December 2014.
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