Status: Ongoing First registered on: 25/09/2019
Last updated on: 31/10/2019
1. Study identification
EU PAS Register NumberEUPAS31529
Official titleA Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Sweden Using the SRQ Register
Study title acronym
Study typeObservational study
Brief description of the studyAn expansion of ongoing post-marketing monitoring of abatacept to include all patients with RA and PsA treated with abatacept with a specific look at select malignancies outcomes.
Was this study requested by a regulator?No
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 applicableBMS IM101-816
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCentre for Pharmacoepidemiology (CPE)
Department/Research groupDepartment of medicine Solna/Clinical epidemiology division
Organisation/affiliationKarolinska Institutet
Website/Homepagehttp://ki.se/en/meds/centre-for-pharmacoepidemiology
Details of (Primary) lead investigator
Title Ms
Last name Dominique
First name Alyssa
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/06/2019
Start date of data collection01/10/201901/10/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report31/05/2025
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 Ms
Last name Dominique
First name Alyssa
Address line 1Route 206 and Provinceline Rd
Address line 2 
Address line 3 
CityPrinceton 
Postcode08543 
CountryUnited States
Phone number (incl. country code)016092523897 
Alternative phone number 
Fax number (incl. country code) 
Email address Alyssa.dominique@bms.com
Public Enquiries
Title Ms 
Last name Dominique 
First name Alyssa 
Address line 1Route 206 and Provinceline Rd 
Address line 2 
Address line 3 
CityPrinceton 
Postcode08543 
CountryUnited States 
Phone number (incl. country code)016092523897 
Alternative phone number 
Fax number (incl. country code) 
Email address Alyssa.dominique@bms.com 
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