An Observational Longitudinal Post-authorization Safety Study of STELARA® in the Treatment of Psoriasis and Psoriatic Arthritis: Analysis of Major Adverse Cardiovascular Events (MACE) using Swedish National Health Registers (QUANTIFY STELARA MACE)

Study identification

• EU PAS number:
  EUPAS49873
• Study ID:
  103700
• Official title and acronym:
  An Observational Longitudinal Post-authorization Safety Study of STELARA® in the Treatment of Psoriasis and Psoriatic Arthritis: Analysis of Major Adverse Cardiovascular Events (MACE) using Swedish National Health Registers (QUANTIFY STELARA MACE)
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study status:
  Finalised

Research institutions and networks

Institutions

Quantify Research

Sweden

Study timelines

Date when funding contract was signed

Actual:24/10/2022

Study start date

Actual:01/07/2009

Date of final study report

Planned:30/06/2023

Actual:12/07/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen-Cilag International NV

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)