Association of tofacitinib with psychiatric disorders

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38716
• EU PAS number:
  EUPAS38690
• Study ID:
  38716
• Official title and acronym:
  Association of tofacitinib with psychiatric disorders
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Descriptive cohort study on occurrence of psychiatric events in incident users of baricitinib, tofacitinib or tocilizumab from January 2017 to June 2020 treated for rheumatoid arthritis.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 24/09/2020

Actual: 24/09/2020

Study start date

Planned: 20/11/2020

Actual: 20/11/2020

Data analysis start date

Planned: 20/11/2020

Actual: 20/11/2020

Date of final study report

Planned: 10/12/2020

Actual: 10/12/2020

Sources of funding

EMA

Regulatory

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