Advanced treatment of ulcerative colitis using an Italian healthcare administrative database: drug utilization patterns, healthcare resource use and costs The MICHELANGELO study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42877
• EU PAS number:
  EUPAS40896
• Study ID:
  42877
• Official title and acronym:
  Advanced treatment of ulcerative colitis using an Italian healthcare administrative database: drug utilization patterns, healthcare resource use and costs The MICHELANGELO study
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  This study will describe the population of users of advanced treatments for Ulcerative Colitis in Tuscany (Italy) between January 1st 2015 to December 31st 2019, including history of disease modifying anti rheumatic drugs (DMARDs) use, accesses to Emergency Department (ED), hospitalizations, access to specialist gastroenterology encounters by means of real world data. This study will also analyze health direct costs associated with the management of this population when treated with advanced treatment.
• Study status:
  Finalised

Research institution and networks

Institutions

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

Italy

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

Italy

Study timelines

Date when funding contract was signed

Planned: 23/04/2021

Actual: 23/04/2021

Study start date

Planned: 26/04/2021

Actual: 26/04/2021

Date of final study report

Planned: 17/05/2021

Actual: 04/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Galapagos Biopharma Italy S.r.l.

Study protocol

Initial protocol

MICHELANGELO study - protocol

Regulatory

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