Study identification

EU PAS number

EUPAS44827

Study ID

50306

Official title and acronym

Impact of EU label changes for medicinal products containing methotrexate for weekly administration: risk awareness and adherence, A survey study

DARWIN EU® study

No

Study countries

France
Germany
Greece
Poland
Sweden

Study description

MTX is authorised in the EU as a chemotherapeutic agent in multiple oncology indications and the low-dose MTX variant is also used as disease-modifying antirheumatic drugs (DMARDs). MTX administration cycle depends on the type of indication being treated, with a weekly low-dose schedule for autoimmune diseases (e.g. rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, steroid sparing adjunctive therapy in Crohn’s disease, acute lymphocytic leukaemia in children) and cycles of different numbers of days with a daily dosing schedule for oncology indications. Inadvertent consumption of prescribed MTX daily doses instead of a single once a week dose, can cause serious overdose issue, sometimes fatal. In 2019, a referral procedure based on pharmacovigilance data concluded that further risk minimisation measures would be required for oral and parenteral MTX containing products, in order to avoid incorrect administration schedules, i.e. inadvertent MTX overdose due to daily use instead of weekly. The survey will measure risk awareness and knowledge amongst healthcare professionals (HCPs) (prescribers and pharmacists) involved in prescribing and dispensing and user of oral and parenteral authorised MTX in the EU following the implementation of the 2019 measures to avoid incorrect administration.

Study status

Finalised
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Massoud Toussi

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable