Randomized clinical trial replication and second-stage study to evaluate the risk of serious infections in biological drug users with psoriatic arthritis and psoriasis using the Italian VALORE distributed database network

Study identification

• EU PAS number:
  EUPAS1000000537
• Study ID:
  1000000537
• Official title and acronym:
  Randomized clinical trial replication and second-stage study to evaluate the risk of serious infections in biological drug users with psoriatic arthritis and psoriasis using the Italian VALORE distributed database network
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  No information provided.
• Study status:
  Ongoing

Research institutions and networks

Institutions

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

Italy

Study timelines

Date when funding contract was signed

Planned:01/01/2020

Study start date

Actual:01/01/2025

Date of final study report

Planned:30/06/2026

Sources of funding

National competent authority (NCAs)

Regulatory

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