Evaluation of the effectiveness of additional risk minimisation measures (aRMM) materials for Xeljanz® (tofacitinib) in Europe via a survey of healthcare professionals (HCPs): A non interventional (NI) post authorisation safety study (PASS)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS43143
• Study ID:
  47503
• Official title and acronym:
  Evaluation of the effectiveness of additional risk minimisation measures (aRMM) materials for Xeljanz® (tofacitinib) in Europe via a survey of healthcare professionals (HCPs): A non interventional (NI) post authorisation safety study (PASS)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Netherlands

  Poland

  Romania

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a cross sectional, non interventional, multimodal survey study that will be conducted among healthcare professionals who have prescribed Xeljanz for rheumatoid arthritis and/or psoriatic arthritis or ulcerative colitis in the 12 months preceding survey administration in 8 European countries (France, Germany, the Netherlands, Poland, Romania, Spain, Sweden, and the United Kingdom [UK]).
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:27/06/2017

Actual:27/06/2017

Study start date

Planned:01/11/2021

Actual:01/11/2021

Date of final study report

Planned:18/04/2023

Actual:14/12/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)