Status: Finalised First registered on: 27/07/2017
Last updated on: 19/09/2018
1. Study identification
EU PAS Register NumberEUPAS20081
Official titleAn observational cohort study to evaluate the risk of adverse pregnancy outcomes in patients treated with etanercept compared to those not treated with etanercept or other biologics using merged data from Sweden, Denmark and Finland
Study title acronym
Study typeObservational study
Brief description of the studyThis is a population-based study of data from the national health registers of Sweden, Denmark and Finland. The study will compare the rate of adverse outcomes, including birth defects, preterm birth, small for gestational age and infections in infancy among infats to women exposed to etanercept with infants to women not exposed.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsCentre for Pharmacoepidemiology (CPE)
Department/Research groupDepartment of medicine/Clinical epidemiology unit
Organisation/affiliationKarolinska Institutet
Website/Homepagehttp://ki.se/en/meds/centre-for-pharmacoepidemiology
Details of (Primary) lead investigator
Title Dr
Last name Kieler
First name Helle
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
Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark
National Institute for Health and Welfare, Helsinki, Finland
Countries in which this study is being conducted
International study

Denmark
Finland
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/07/201701/07/2017
Start date of data collection01/07/200601/07/2006
Start date of data analysis01/07/201701/07/2017
Date of interim report, if expected
Date of final study report31/12/201802/07/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Kieler
First name Helle
Address line 1Department of medicine
Address line 2Centre for Pharmacoepidemiology, T2 
Address line 3Karolinska University Hospital Solna 
CityStockholm 
Postcode171 76 
CountrySweden
Phone number (incl. country code)46851770629 
Alternative phone number46736334492 
Fax number (incl. country code)46851779304 
Email address helle.kieler@ki.se
Public Enquiries
Title Dr 
Last name Kieler 
First name Helle 
Address line 1Department of medicine 
Address line 2Centre for Pharmacoepidemiology, T2 
Address line 3Karolinska University Hospital Solna 
CityStockholm 
Postcode171 76 
CountrySweden 
Phone number (incl. country code)46851770629 
Alternative phone number46736334492 
Fax number (incl. country code)46851779304 
Email address helle.kieler@ki.se 
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