Risk of serious infections with bDMARDs in psoriasis/psoriatic arthritis patients: a large-scale cohort study using the Italian VALORE Project distributed database

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106605
• EU PAS number:
  EUPAS105426
• Study ID:
  106605
• Official title and acronym:
  Risk of serious infections with bDMARDs in psoriasis/psoriatic arthritis patients: a large-scale cohort study using the Italian VALORE Project distributed database
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pharmacology Unit - Veneto Pharmacovigilance Centre (Pharmacol UNIVR), University Hospital Verona

Italy

Sezione di Farmacologia,Dipartimento di Diagnostica e Sanità Pubblica

Several regions Italy

Study timelines

Date when funding contract was signed

Actual: 01/01/2021

Study start date

Actual: 01/04/2023

Date of final study report

Planned: 31/12/2023

Sources of funding

Other

More details on funding

AIFA

Study protocol

Initial protocol

Protocollo_Severe_Infectious_Diseases_In_Dermatology_final

Updated protocol

Protocollo_Severe_Infectious_Diseases_In_Dermatology_Nuova versione_1

Regulatory

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