MEMO

• Research type

  Research Study

• Full title

  Measurement of methotrexate and 7-OH-methotrexate metabolites in urine and blood of patients with rheumatoid arthritis: a possible measure of Methotrexate adherence

• IRAS ID

  128563

• Contact name

  James Bluett

• Contact email

  james.bluett@manchester.ac.uk

• Sponsor organisation

  The University of Manchester

• Research summary

  Methotrexate (MTX) is now the disease modifying drug (DMARD) of first choice for most patients with rheumatoid arthritis (RA). However response to MTX, although better than most other conventional DMARDs, is not universal. Some patients experience no improvement in their disease despite adequate doses of the medication (inefficacy) while others have to stop taking the drug because of adverse events (AEs). Up to 54% of patients do not respond to MTX but between 18% and 40% are believed to be non-adherent with MTX therapy (i.e. do not take their MTX as instructed by their doctors).

  Non-adherence to MTX is a major contributor to non-response to therapy. Adherence is therefore an important factor in treatment response and an objective measure to detect non-adherence is yet to be developed. Medication adherence - the extent to which patients take medications as prescribed by their providers and agreed upon in their treatment plan –is therefore essential for optimising health outcomes. However, an objective measure to detect MTX non-adherence is yet to be developed.
  In the body, MTX is broken down to other constituents (including the metabolite 7-OH-MTX) which control the inflammation in RA. Measuring these may determine which patients are taking their medication.

  A biochemical test has been developed which can detect MTX and its metabolite 7-OH-MTX in blood and urine.

  The aim of this study is to investigate the ability of this biochemical test to measure MTX adherence in patients with RA treated with MTX as part of their routine care.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  13/NW/0653

• Date of REC Opinion

  28 Oct 2013

• REC opinion

  Further Information Favourable Opinion