Status: Planned First registered on: 30/07/2018
Last updated on: 29/07/2020
1. Study identification
EU PAS Register NumberEUPAS25027
Official titlePregnancy outcomes in women exposed to oral cladribine: a multi-country cohort database study
Study title acronymCLEAR
Study typeObservational study
Brief description of the studyThe design of this pregnancy PASS is a cohort study based on secondary use of data from various automated healthcare databases (AHDB) and registers in 7 European countries: Denmark, Finland, France, Germany, Norway, Sweden, and Scotland (United Kingdom). Women with Multiple Sclerosis (MS) who were exposed to oral cladribine during pregnancy and/or within 6 months before their last menstrual period (LMP) (i.e. exposure period, which correspond to the at-risk period for pregnancy outcomes, major congenital anomalies (MCA) in infants or alternations in growth and development in infants), or pregnancies fathered by men with MS treated with oral cladribine within 6 months before their LMP, will be identified in the selected databases/registers. Data will be retrieved on pregnancies and their outcomes, and infants for MCA, growth and development. Comparison of pregnancy outcomes will be conducted in pregnant women with MS between the exposed cohort (exposure to oral cladribine within the at-risk period) and the unexposed cohort (unexposed to any Disease-modifying drug [DMD] during the at-risk period, which can vary from 3 to 12 months according to the DMD) and in pregnant women whose pregnancy is fathered by men with MS between the exposed cohort (pregnancy fathered by men with MS exposed to oral cladribine within the at-risk period) and the unexposed cohort (pregnancy fathered by men with MS unexposed to any DMD during the at-risk period, which can vary from 3 to 6 months according to the DMD). In the selected data sources, pregnancies will be followed until the outcome of the pregnancy is known, and live births resulting from an identified pregnancy will be followed for up to one year of age.
Was this study requested by a regulator?Yes: Denmark, Finland, France, Germany, Norway, Sweden, United Kingdom
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 belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Alejandro
First name Arana
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?7

Centre for Pharmacoepidemiology (CPE)
Drugs and Pregnancy, THL
MEMO
Danish Multiple Sclerosis Registry, Denmark
Observatoire français de la sclérose en plaques (OFSEP), France
German MS Pregnancy Registry, Germany
Norwegian MS-registry and biobank, Norway
Countries in which this study is being conducted
International study

Denmark
Finland
France
Germany
Norway
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/12/201809/09/2019
Start date of data collection31/12/2020
Start date of data analysis31/12/2027
Date of interim report, if expected30/12/2023
Date of final study report28/07/2028
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMerck Healthcare KGaA100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Merck Healthcare KGaA
First name Communication Center
Address line 1Frankfurter Str. 250
Address line 2 
Address line 3 
CityDarmstadt 
Postcode64293 
CountryGermany
Phone number (incl. country code)49-6151-725200 
Alternative phone number 
Fax number (incl. country code) 
Email address service@merckgroup.com
Public Enquiries
Title Dr 
Last name Merck Healthcare KGaA 
First name Communication Center 
Address line 1Frankfurter Str. 250 
Address line 2 
Address line 3 
CityDarmstadt 
Postcode64293 
CountryGermany 
Phone number (incl. country code)49-6151-725200 
Alternative phone number 
Fax number (incl. country code) 
Email address service@merckgroup.com 
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