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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50306
• 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

Study timelines

Date when funding contract was signed

Actual: 10/05/2021

Study start date

Planned: 01/02/2022

Actual: 25/02/2022

Data analysis start date

Planned: 19/04/2022

Actual: 19/04/2022

Date of final study report

Planned: 12/09/2022

Actual: 04/10/2022

Sources of funding

EMA

Study protocol

Initial protocol

Methotrexate Protocol_v1.0

Updated protocol

SC02 EMA2018_19_PE_Methotrexate Protocol_v2.0_21 Feb 2022_Signed

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable