Retrospective Post-Marketing Safety Surveillance Study of Tofacitinib in Psoriatic Arthritis (PsA) and Rheumatoid Arthritis (RA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50422
• EU PAS number:
  EUPAS46286
• Study ID:
  50422
• Official title and acronym:
  Retrospective Post-Marketing Safety Surveillance Study of Tofacitinib in Psoriatic Arthritis (PsA) and Rheumatoid Arthritis (RA)
• DARWIN EU® study:
  No
• Study countries:
  Canada
• Study description:
  To describe the demographics and clinical characteristics of Psoriatic Arthritis or Rheumatoid Arthritis patients treated with tofacitinib for whom adverse events have been reported in the Pfizer Safety database. To characterize the type and reporting rate of adverse events reported in patients receiving tofacitinib for Psoriatic Arthritis or Rheumatoid Arthritis reported in the Pfizer Safety database.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 01/04/2022

Actual: 16/09/2022

Study start date

Planned: 22/09/2022

Actual: 03/10/2022

Date of final study report

Planned: 06/09/2023

Actual: 13/11/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921421 Non-Interventional Protocol Study Version 1.0_ 30 August 2022_Redacted

Updated protocol

A3921421 Non-Interventional Protocol Study Amendment 1_v2.0_(clean) 07 December 2022_Redacted

Regulatory

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