Status: Finalised First registered on: 24/06/2015
Last updated on: 15/02/2018
1. Study identification
EU PAS Register NumberEUPAS10046
Official titleEvaluation of the effectiveness of the belatacept (Nulojix®) Patient Alert Card in patients following renal transplantation in European Economic Area countries.
Study title acronym
Study typeObservational study
Brief description of the studyThis is a study that evalustes the effectiveness of the belatacept patient alert card (PAC). Three epidemiological sub-studies will be conducted to make this evaluation: a patient survey of understanding and implementation of the key messages in the belatacept PAC, a health care professional (HCP) survey of understanding and implementation of the key messages in the belatacept PAC and a a Clinical Outcomes Study using retrospective chart review to correlate clinical and safety outcomes with levels of understanding and implementation of the key messages in the PAC.
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 belongsOXON
Department/Research group
Organisation/affiliationOxon Epidemiology Ltd.
Website/Homepagewww.oxonepi.com
Details of (Primary) lead investigator
Title Dr
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
First name Nawab
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?20
Countries in which this study is being conducted
International study

Austria
France
Germany
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed05/08/201405/08/2014
Start date of data collection01/10/201601/10/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report15/01/201825/01/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBristol Myers Squibb100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
First name Nawab
Address line 1The Euston Office
Address line 21 Euston Square 
Address line 340 Melton Street 
CityLondon 
PostcodeNW1 2FD 
CountryUnited Kingdom
Phone number (incl. country code)34-629846059 
Alternative phone number 
Fax number (incl. country code)442033977497 
Email address n.qizilbash@oxonepi.com
Public Enquiries
Title Dr 
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.) 
First name Nawab 
Address line 1The Euston Office 
Address line 21 Euston Square 
Address line 340 Melton Street 
CityLondon 
PostcodeNW1 2FD 
CountryUnited Kingdom 
Phone number (incl. country code)34-629846059 
Alternative phone number 
Fax number (incl. country code)442033977497 
Email address n.qizilbash@oxonepi.com 
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