Drug utilisation study of upadacitinib (Rinvoq™) in Europe to evaluate the effectiveness of additional risk minimisation measures

Study identification

• EU PAS number:
  EUPAS39211
• Study ID:
  47974
• Official title and acronym:
  Drug utilisation study of upadacitinib (Rinvoq™) in Europe to evaluate the effectiveness of additional risk minimisation measures
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Spain

  Sweden

  United Kingdom (Northern Ireland)
• Study description:
  This study aims to characterise the use of upadacitinib (Rinvoq™) in routine clinical care, including describing baseline characteristics of individuals with rheumatoid arthritis exposed to upadacitinib relative to individuals with rheumatoid arthritis exposed to other systemic treatments. This study also aims to evaluate the effectiveness of additional risk minimisation measures.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Study timelines

Date when funding contract was signed

Planned:25/11/2020

Actual:25/11/2020

Study start date

Planned:01/01/2020

Actual:15/06/2021

Date of final study report

Planned:30/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

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)

Other study registration identification numbers and links

P20-199