An Observational, Post-Authorization Safety Study (PASS) within the Consortium of Rheumatology Researchers of North America (CORRONA) Registry ComparingRates of Malignancy, Cardiovascular and Serious Infection Outcomes among Patients Treated for Moderately to Severely Active Rheumatoid Arthritis (CORRONA Surveillance PASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34710
• EU PAS number:
  EUPAS5708
• Study ID:
  34710
• Official title and acronym:
  An Observational, Post-Authorization Safety Study (PASS) within the Consortium of Rheumatology Researchers of North America (CORRONA) Registry ComparingRates of Malignancy, Cardiovascular and Serious Infection Outcomes among Patients Treated for Moderately to Severely Active Rheumatoid Arthritis (CORRONA Surveillance PASS)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Tofacitinib is a potent, selective inhibitor of the Janus kinase family of kinases with a high degree of selectivity against other kinases in the human genome. To enable assessment of rare events and endpoints with long latency periods, Pfizer will implement a post-approval, population-based active surveillance study of tofacitinib-exposed patients using the Consortium of Rheumatology Researchers of North America registry to actively collect data in a prospective manner.
• Study status:
  Finalised

Research institutions and networks

Institutions

CORRONA

Study timelines

Date when funding contract was signed

Planned: 02/01/2013

Actual: 15/07/2013

Study start date

Planned: 04/12/2012

Actual: 04/12/2012

Date of final study report

Planned: 31/12/2019

Actual: 13/03/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer, Inc.

Study protocol

Initial protocol

A3921205_PROTOCOL_23DEC2013

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)