Study identification

PURI

https://redirect.ema.europa.eu/resource/47503

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 institution and networks

Institutions

Pfizer
First published:
01/02/2024
Institution

Contact details

Andrea Leapley

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc
Study protocol
Initial protocol

A3921334 Evaluation of the effectiveness of addiitonal risk minimisation (aRMM) materials for Xeljanz (tofacitibib) in Europe via a survey of healthcare professionals (HCPs)

English (6.34 MB - PDF)View document
Updated protocol

A3921334_PROTOCOL- XELJANZ HCP SURVEY CLEAN_V3.0_28MAR2022

English (1.46 MB - PDF)View document
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)