Methotrexate Study

Introduction

The research is being led by Prof Guru Aithal, a Professor of Hepatology in at Nottingham University Hospital NHS Trust (NUH) and Nottingham Digestive Diseases Centre. The study is funded by the NIHR Nottingham Biomedical Research Centre

Who can participate?

Men & women aged over 18 who:

  • are taking methotrexate to treat rheumatoid arthritis or psoriasis
  • or are considering taking methotrexate

to investigate the effectiveness of certain non-invasive tests in detecting liver scarring/damage in patients

Participation involves:

One visit to see the research nurse usually as part of your routine clinical visit.

You will be asked to:

  • have a simple health check (weight, blood pressure etc)
  • provide a blood sample (at the same time as standard blood testing),
  • undergo a Fibroscan (similar to ultrasound scan)
  • provide your medical history & medication

The research nurse will try to answer any questions you have and discuss you health and medical history. A Fibroscan is painless and you are advised to not eat 4 hours before.

Prof Guru Aithal with Fibroscan machine
Prof Guru Aithal with Fibroscan machine

Purpose of the study

To investigate the effectiveness of certain non-invasive tests in the detection of liver scarring in patients with rheumatoid arthritis or psoriasis who are currently on methotrexate.

Study Aims

This research will:

  • Compare the ability of 4 different methods to detect liver damage/scarring in patients taking methotrexate. These methods are liver biopsy, fibroscan, current standard liver function tests and new ELF tests.
  • Determine the prevalence of liver scarring in patients with rheumatoid arthritis and psoraisis (taking or not taking methotrexate)
  • Investigate whether genetic factors contribute to risk of liver scarring in patients

Our Goal

To develop the best diagnostic testing programme to ensure liver health is closely monitored in patients taking methotrexate.

What will be done with my samples?

  • We will measure various substances and constituents of your blood which can indicate your liver health.
  • We may send samples to research teams at other institutions for collaborative research, or to commercial service providers for specialist analysis. These may be within or outside the UK. All samples and medical details will be fully anonymised so you cannot be identified. We will comply with the Human Tissue Act and other International laws.
  • We will asses your blood samples for gene patterns and variations which are relevant to scarring of the liver.
  • We will not carry out any form of genetic testing of your samples to detect inherited disorders
  • We would like to store the samples collected from you after the research project has ended for future research studies by us or collaborators at other institutions. We will ask your permission to do this - You will need to indicate on your consent form if you would like your samples to be stored or not.
  • Any samples or data used will be anonymised and you will not be identifiable.

Key facts about Methotrexate therapy

  • Methotrexate is an anti-rheumatic drug widely used to treat rheumatoid arthritis and psoriasis for more than 50 years.
  • However, there is evidence to suggest that long term use of methotrexate may lead to liver injury and scarring in some patients
  • Various guidelines have therefore been developed for doctors to monitor liver health in patients taking methotrexate:
  • A liver biopsy is recommended to assess the liver but this is not ideal and new non-invasive tests have now become available – e.g. Fibroscan or blood tests such as enhanced liver fibrosis (ELF) test.
  • It is not yet clear how many patients taking methotrexate develop liver problems or whether the non-invasive monitoring is reliable.

For information about liver disease

www.nhs.uk/conditions/liver-disease/

www.britishlivertrust.org.uk

If you have questions or concerns about any aspect of the study, please contact the research team members:

Ruth Shephard, Research/Specialist Nurse on Tel: 0115 9249924 ext 70615 Email: ruth.shephard@nuh.nhs.uk

BRC reception on Tel: 0115 9709966 Email: nddcbru@nottingham.ac.uk

Contact Us