Status: Finalised First registered on: 10/06/2020
Last updated on: 16/10/2020
1. Study identification
EU PAS Register NumberEUPAS35746
Official titleUtilization patterns, access to healthcare facilities and economic assessment of JAKi drugs used in rheumatoid arthritis patients in Tuscany: the LEONARDO study
Study title acronymLEONARDO
Study typeObservational study
Brief description of the studyIn this study, we will identify new users of JAKi in Tuscany from their approval in the treatment of severe to moderate RA in 2018 to 2019, and describe their utilization of the Regional Healthcare System facilities after treatment initiation, including an economic assessment. Since JAKi are used as second line in patients with moderate to severe RA non-responders to biologic DMARDs, we will provide an estimation over time of the new users of bDMARDs with and without history of access to rheumatoid arthritis wards in Tuscany.
Was this study requested by a regulator?No
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 belongsUADRM
Department/Research groupUnit of adverse drug reactions monitoring
Organisation/affiliationUniversity hospital of Pisa
Website/Homepagehttp://www.ao-pisa.toscana.it/index.php?option=com_content&view=article&id=2256%3Asez-dip-monitoraggio-reazioni-avverse-ai-farmaci&catid=383&Itemid=54; http://www.medmcs.unipi.it/laboratorio-pharmacovigilance-and-drug-safety.html
Details of (Primary) lead investigator
Title Professor
Last name Blandizzi
First name Corrado
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?3

ARS
Pisa, Scuola Superiore Sant'Anna
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/06/202001/07/2020
Start date of data collection30/06/202001/07/2020
Start date of data analysis06/07/202010/07/2020
Date of interim report, if expected
Date of final study report31/07/202016/10/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGalapagos NV100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Tuccori
First name Marco
Address line 1via Roma 55
Address line 2 
Address line 3 
CityPisa 
Postcode56126 
CountryItaly
Phone number (incl. country code)39-050-2218761 
Alternative phone number 
Fax number (incl. country code) 
Email address marco.tuccori@gmail.com
Public Enquiries
Title Dr 
Last name Tuccori 
First name Marco 
Address line 1via Roma 55 
Address line 2 
Address line 3 
CityPisa 
Postcode56126 
CountryItaly 
Phone number (incl. country code)39-050-2218761 
Alternative phone number 
Fax number (incl. country code) 
Email address marco.tuccori@gmail.com 
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