A Prospective Observational Study within the Corrona International Registry to Evaluate Safety and Effectiveness of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in Japan among Patients Treated for Moderately to Severely Active Rheumatoid Arthritis

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44699
• EU PAS number:
  EUPAS13155
• Study ID:
  44699
• Official title and acronym:
  A Prospective Observational Study within the Corrona International Registry to Evaluate Safety and Effectiveness of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in Japan among Patients Treated for Moderately to Severely Active Rheumatoid Arthritis
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  This project has been terminated due to lack of participation of subjects in the registry. No study report or publications will be made for this project.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 01/06/2015

Actual: 17/06/2015

Study start date

Planned: 21/06/2016

Actual: 21/06/2016

Data analysis start date

Actual: 21/06/2016

Date of interim report, if expected

Actual: 21/06/2016

Date of final study report

Planned: 30/09/2023

Actual: 29/10/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921256_PROTOCOL_V1.0_01FEB2016

Regulatory

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