Status: Finalised First registered on: 15/04/2016
Last updated on: 17/05/2022
1. Study identification
EU PAS Register NumberEUPAS13054
Official titleEPID Multiple Sclerosis Pregnancy study - Pregnancy outcomes in Multiple Sclerosis populations exposed and unexposed to interferon beta - a register-based study in the Nordic countries
Study title acronymEPID Multiple Sclerosis Pregnancy study
Study typeObservational study
Brief description of the studyMS 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA
Department/Research groupIQVIA Global Database Studies
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Dr
Last name Toussi
First name Massoud
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

Centre for Pharmacoepidemiology (CPE)
IQVIA Global Database Studies
Haukeland University Hospital, Bergen, Norway
Countries in which this study is being conducted
International study

Finland
Norway
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/12/2012
Start date of data collection02/05/201602/05/2016
Start date of data analysis31/10/2017
Date of interim report, if expected
Date of final study report31/12/201807/06/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer Pharma AG, Biogen Idec Ltd, Merck Serono Europe Ltd, Novartis Pharma AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Korhonen
First name Pasi
Address line 1Global Database Studies, IQVIA
Address line 2Spektri, Duo Building, Metsänneidonkuja 6 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland
Phone number (incl. country code)358408643912 
Alternative phone number 
Fax number (incl. country code) 
Email address ENCePP@iqiva.com
Public Enquiries
Title Mrs 
Last name Juuti 
First name Rosa 
Address line 1Global Database Studies, IQVIA 
Address line 2Spektri, Duo Building, Metsänneidonkuja 6 
Address line 3 
CityEspoo 
Postcode02130 
CountryFinland 
Phone number (incl. country code)358408643912 
Alternative phone number 
Fax number (incl. country code) 
Email address ENCePP@iqvia.com 
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