Long-term comparative safety cohort studies of upadacitinib (Rinvoq™) use for the treatment of RA in Europe

Study identification

• EU PAS number:
  EUPAS39217
• Study ID:
  47968
• Official title and acronym:
  Long-term comparative safety cohort studies of upadacitinib (Rinvoq™) use for the treatment of RA in Europe
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Spain

  Sweden

  United Kingdom (Northern Ireland)
• Study description:
  The purpose of this study is to evaluate and characterise the important identified and potential risks of upadacitinib (Rinvoq™) and missing information on the safety of upadacitinib, as described in the European Union (EU) Risk Management Plan (RMP) for Rinvoq™ (upadacitinib). This study aims to evaluate the long-term safety of upadacitinib among patients with RA receiving routine clinical care.
• 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:31/03/2030

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

P19-150