Study identification

PURI

https://redirect.ema.europa.eu/resource/47492

EU PAS number

EUPAS46910

Study ID

47492

Official title and acronym

A Post-Authorisation Safety Study of the Utilisation and Prescribing Patterns of Xeljanz® (tofacitinib) in the European Union Using Secondary Data Sources

DARWIN EU® study

No

Study countries

Germany
Hungary
Netherlands
Sweden

Study description

Tofacitinib citrate (Xeljanz®) is an oral Janus kinase inhibitor approved by the European Commission (EC) for the treatment of adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ulcerative colitis (UC). To minimise important potential and identified risks associated with the use of tofacitinib, the Marketing Authorisation Holder (MAH) implemented additional risk minimisation measures (aRMMs). This protocol describes a drug utilisation study to assess prescribing patterns of tofacitinib and whether there is evidence that prescribers are following the screening and monitoring recommendations and limitations for use included in the aRMM materials for patients prescribed tofacitinib, as well as any potential off-label use of tofacitinib, contraindicated use, and use with concomitant medications not compatible with tofacitinib. Additionally, as a result of the 2019 benefit-risk reassessment requested by the EC pursuant to Article 20 of Regulation (EC) No 726/2004, as well as the 2021 signal evaluation procedure, the MAH will evaluate healthcare professionals’ compliance with the new Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and limitations for use implemented after the 2019 Article 20 referral to minimise the risk of venous thromboembolism (VTE), use in elderly patients aged ≥65 years, and mortality, and after the signal evaluation procedure to assess use in patients with cardiovascular (CV) risk factors and use in patients with malignancy risk factors.

Study status

Ongoing
Research institutions 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

Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc
Study protocol
Initial protocol

A3921321 Protocol 11 Feb 2022

English (1.54 MB - PDF)View document
Updated protocol

A3921321_PROTOCOL- EU DUS_V5.0_11FEB2022

English (1.8 MB - PDF)View document
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)