Status: Planned First registered on: 04/04/2019
Last updated on: 09/09/2020
1. Study identification
EU PAS Register NumberEUPAS29263
Official titleExPloring efficAcy, safeTy, and adHerence oF dIsease-modifyiNg antirheumatic Drugs through trajEctoRy model: the PATHFINDER study
Study title acronymthe PATHFINDER study
Study typeObservational study
Brief description of the studyThis project will evaluate the utilization, adherence, efficacy, and safety of disease modifying antirheumatic drugs employed for the management of rheumatoid arthritis in the Tuscan population by means of real world data. This research will identify patterns of utilization of rheumatoid arthritis treatments and their predictors, and it will explore the relationship of these trajectories with endpoints of effectiveness and safety.
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 applicableProtocol n.18724 of Tuscan Regional Ethics Committee for Clinical Trials
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 Dr
Last name Tuccori
First name Marco
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

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/03/201929/03/2019
Start date of data collection13/05/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherPisa University Hospital100
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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