Status: Finalised First registered on: 08/10/2014
Last updated on: 05/12/2022
1. Study identification
EU PAS Register NumberEUPAS7574
Official titleInternational LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
Study title acronymOBS13436
Study typeObservational study
Brief description of the studyA voluntary post authorization safety study (PASS). An international, prospective, observational cohort study (registry) of pregnancy outcomes in women with multiple sclerosis exposed to LEMTRADA during pregnancy. The overall goal of the study is to evaluate pregnancy outcomes in women exposed to LEMTRADA during pregnancy and to determine if the risk of any adverse pregnancy outcomes in these women exceeds the risks in women with MS who have not been exposed to LEMTRADA during pregnancy. Specific outcomes to be assessed include: spontaneous abortion, stillbirth, fetal major malformations, preterm birth, and small for gestational age at birth. To further characterize prenatally-exposed live births, outcomes in the neonatal and pediatric periods up to one year of age will be assessed pending available data.
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 nameSanofi
Centre locationChilly Mazarin
Details of (Primary) lead investigator
Title Dr
Last name Trial Transparency Team
First name Trial Transparency Team
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Australia
Austria
Belgium
Canada
Denmark
Germany
Italy
Netherlands
Spain
Sweden
Switzerland
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/09/201408/09/2014
Start date of data collection30/11/201401/09/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report04/11/202209/11/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGenzyme a Sanofi Company100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Trial Transparency Team
First name Trial Transparency Team
Address line 11 Avenue Pierre Brossolette
Address line 2 
Address line 3 
CityChilly-Mazarin 
Postcode 
CountryFrance
Phone number (incl. country code)33160497777 
Alternative phone number 
Fax number (incl. country code) 
Email address contact-US@sanofi.com
Public Enquiries
Title Dr 
Last name Trial Transparency Team 
First name Trial Transparency Team 
Address line 11 Avenue Pierre Brossolette 
Address line 2 
Address line 3 
CityChilly-Mazarin 
Postcode 
CountryFrance 
Phone number (incl. country code)33160497777 
Alternative phone number 
Fax number (incl. country code) 
Email address contact-US@sanofi.com 
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