Study identification

PURI

https://redirect.ema.europa.eu/resource/47377

EU PAS number

EUPAS13054

Study ID

47377

Official title and acronym

EPID Multiple Sclerosis Pregnancy study - Pregnancy outcomes in Multiple Sclerosis populations exposed and unexposed to interferon beta - a register-based study in the Nordic countries

DARWIN EU® study

No

Study countries

Finland
Norway
Sweden

Study description

MS disease is the most common chronic neurologic disability in young adult females in their childbearing ages. It is commonly understood that relapses are fewer during pregnancy, but also that medication taken before conception or in early pregnancy could negatively affect pregnancy outcomes. Experience about exposure to MS disease modifying drugs (MSDMDs) during pregnancy has been mostly collected from IFN-βs and glatiramer acetate with no clear association of adverse outcomes such as low birth weight, congenital anomaly or spontaneous abortion. However, it is contraindicated to initiate treatment with IFN-β products during pregnancy. Furthermore, information on newer MSDMD substances such as fingolimod from previous studies is limited. Due to limited evidence being available regarding the association between exposure to IFN-β products and adverse pregnancy outcomes the four marketing authorization holders (MAHs) of IFN-β are conducting a European-wide IFN-β pregnancy registry. Additionally, the Committee for the 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. The overall research questions of this study are to determine if exposure to IFN-β before or during pregnancy has an adverse effect on pregnancy outcomes in patients with MS and, as requested by the CHMP, to identify the prevalence of adverse pregnancy outcomes in MS women unexposed to IFN-β products.

Study status

Finalised
Research institution and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution
Non-Pharmaceutical companyENCePP partner
Haukeland University Hospital Bergen, Norway

Contact details

Massoud Toussi

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer Pharma AG, Biogen Idec Ltd, Merck Serono Europe Ltd, Novartis Pharma AG
Study protocol
Initial protocol

ER-9430-EPID Research PASS study protocol_version 2.0 v5_2015-08-18_CLEAN

English (1.13 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)