Utilization patterns, access to healthcare facilities and economic assessment of JAKi drugs used in rheumatoid arthritis patients in Tuscany: the LEONARDO study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37637
• EU PAS number:
  EUPAS35746
• Study ID:
  37637
• Official title and acronym:
  Utilization patterns, access to healthcare facilities and economic assessment of JAKi drugs used in rheumatoid arthritis patients in Tuscany: the LEONARDO study
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  In 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Unit of adverse drug reactions monitoring (UADRM), University Hospital of Pisa

Italy

Pisa Scuola Superiore Sant'Anna

Study timelines

Date when funding contract was signed

Planned: 15/06/2020

Actual: 01/07/2020

Study start date

Planned: 30/06/2020

Actual: 01/07/2020

Data analysis start date

Planned: 06/07/2020

Actual: 10/07/2020

Date of final study report

Planned: 31/07/2020

Actual: 16/10/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Galapagos NV

Study protocol

Initial protocol

Study protocol (ENCEPP REGISTRY)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable