Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000247

EU PAS number

EUPAS1000000247

Study ID

1000000247

Official title and acronym

A Post-Authorisation Safety Study of the Utilisation and Prescribing Patterns of Xeljanz® (tofacitinib) Using an Administrative Healthcare Database in France

DARWIN EU® study

No

Study countries

France

Study description

Tofacitinib citrate (Xeljanz®) is an oral Janus kinase inhibitor approved by the European Commission (EC) for the treatment of adults with moderate-tosevere rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC) and other indications (i.e., ankylosing spondylitis and juvenile idiopathic arthritis). To minimise important identified and potential risks associated with the use of tofacitinib, the Marketing Authorisation Holder (MAH) implemented additional risk minimisation measures (aRMMs). This is a drug utilisation study to assess prescribing patterns of tofacitinib and whether prescribers are adherent to 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, the 2021 signal evaluation procedure, and the 2022/2023 Janus kinase inhibitors (JAKi) Article 20 referral, the MAH will evaluate healthcare professionals’ adherence to the new Pharmacovigilance Risk Assessment Committee 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 older, and mortality, after the signal evaluation procedure to assess use in patients with cardiovascular (CV) risk factors and use in patients with malignancy risk factors, and after the latest JAKi referral to assess the updated recommendations for use in patients with VTE, CV and malignancy risk factors.

Study status

Planned
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution

Contact details

Saranya Nair

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

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 100%
Study protocol
Initial protocol

A3921403_PROTOCOL- FRANCE DUS_V4.0_26FEB2024.pdf

English (1.85 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)