Status: Planned First registered on: 26/06/2019
Last updated on: 14/01/2021
1. Study identification
EU PAS Register NumberEUPAS30280
Official titleThe BRodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) study in electronic healthcare databases
Study title acronymBRAHMS
Study typeObservational study
Brief description of the study
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 belongsUniversity of Southern Denmark Pharmacoepi center
Department/Research groupOdense University Pharrnacoepidemiological Database
Organisation/affiliationUniversity of Southern Denmark
Website/Homepage
Details of (Primary) lead investigator
Title Professor
Last name Hallas
First name Jesper
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?8

ARS
Countries in which this study is being conducted
International study

Denmark
Germany
Italy
Netherlands
Norway
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/04/2018
Start date of data collection01/01/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report30/09/2030
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesLEO Pharma100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Hallas
First name Jesper
Address line 1JB Winsløwsvej 19,2
Address line 2 
Address line 3 
CityOdense C 
PostcodeDK-5000 
CountryDenmark
Phone number (incl. country code)45-65503010 
Alternative phone number45-60191182 
Fax number (incl. country code)45-65916089 
Email address jhallas@health.sdu.dk
Public Enquiries
Title Professor 
Last name Hallas 
First name Jesper 
Address line 1JB Winsløwsvej 19,2 
Address line 2 
Address line 3 
CityOdense C 
PostcodeDK-5000 
CountryDenmark 
Phone number (incl. country code)45-65503010 
Alternative phone number45-60191182 
Fax number (incl. country code)45-65916089 
Email address jhallas@health.sdu.dk 
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