Status: Finalised First registered on: 30/06/2015
Last updated on: 21/08/2019
1. Study identification
EU PAS Register NumberEUPAS10122
Official titleEvaluation of the effectiveness of the abatacept (ORENCIA®) intravenous and subcutaneous formulation Patient Alert Cards in patients with rheumatoid arthritis in a sample of European Economic Area countries
Study title acronym
Study typeObservational study
Brief description of the studyThe patient alert cards (PACs) for the use of intravenous (IV) and subcutaneous (SC) formulations of abatacept are to be evaluated as part of the post-marketing commitment to the European Medicines Agency (EMA) by Bristol-Myers Squibb (BMS). Three epidemiological sub-studies will be conducted: a patient survey of understanding and implementation of the key messages in the abatacept PACs, a health care professional (HCP) survey of understanding and implementation of the key messages in the abatacept PACs and 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 PACs.
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 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?40
Countries in which this study is being conducted
International study

France
Germany
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed05/10/2014
Start date of data collection15/10/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report07/09/2017
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 116 Upper Woburn Place
Address line 2 
Address line 3 
CityLondon 
PostcodeWC1H 0AF 
CountryUnited Kingdom
Phone number (incl. country code)34-629846059 
Alternative phone number44-2035744965 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.) 
First name Nawab 
Address line 116 Upper Woburn Place 
Address line 2 
Address line 3 
CityLondon 
PostcodeWC1H 0AF 
CountryUnited Kingdom 
Phone number (incl. country code)34-913459395 
Alternative phone number44-02037418054 
Fax number (incl. country code) 
Email address oxon@oxonepi.com 
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