An Observational Study of Xeljanz® (tofacitinib citrate) and Biologic Rheumatoid Arthritis Treatments to Characterize their General Treatment Patterns, Effectiveness and Safety in a Real-World Taiwanese Population

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48622
• EU PAS number:
  EUPAS13431
• Study ID:
  48622
• Official title and acronym:
  An Observational Study of Xeljanz® (tofacitinib citrate) and Biologic Rheumatoid Arthritis Treatments to Characterize their General Treatment Patterns, Effectiveness and Safety in a Real-World Taiwanese Population
• DARWIN EU® study:
  No
• Study countries:
  Taiwan
• Study description:
  Update - administrative updates were needed to the final study report and are addressed in the summary of changed document I have attached. The main objective of this multicenter, prospective, observational comparative effectiveness study in Taiwan is to understand general treatment patterns, effectiveness, and safety of tofacitinib compared to TNFi in a non-restricted population of RA patients in the real-world setting.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

IQVIA

United Kingdom

Taipei Veterans General Hospital Taipei, Tri-Service General Hospital Taipei, Taichung Veterans General Hospital Taichung City, Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, Kaohsiung Veterans General Hospital Kaohsiung City, National Taiwan University Hospital Taipei City, China Medical University Hospital Taichung City

Study timelines

Date when funding contract was signed

Planned: 25/12/2015

Actual: 25/12/2015

Study start date

Planned: 15/04/2016

Actual: 12/08/2016

Date of final study report

Planned: 30/04/2022

Actual: 01/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A3921275_PROTOCOL_V1.0_01FEB2016 (for EU PAS register)

Updated protocol

A3921275 Non-Interventional PROTOCOL Amendment 1 (clean version 2) 16 March 2022_Redacted

Regulatory

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