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PROMOTE: A trial of methotrexate to treat painful knee osteoarthritis

Award Details

  • Principal Investigator
    Professor Philip Conaghan
  • Type of grant
    ZZZ-Clinical Studies
  • Amount Awarded
  • Institute
    University of Leeds
  • Location
  • Status
  • Start Date
  • Grant reference number
  • Condition
    Knee pain, Osteoarthritis

What are the aims of this research?

This clinical study will investigate whether methotrexate is an effective treatment for reducing pain in people with knee osteoarthritis (OA) compared to a placebo. A form of imaging called magnetic resonance imaging (MRI) will also be used to examine whether methotrexate reduces inflammation within the OA joint. The results of these imaging studies will aid understanding of how methotrexate works.

Why is this research important?

In the UK an estimated 8.5 million people are affected by OA, causing an enormous burden to health authorities and to the UK economy as well as considerable pain and disability to individuals affected. The number of people with OA in the UK has increased 2-4 times over the last 50 years as is expected to grow considerably with an ageing population, placing an unsustainable burden on health services and the economy. Current treatments for knee OA are limited to painkillers and surgery and as a result people with OA often live with severe pain and have significant difficulty in carrying out their normal day-to-day activities. There is therefore an urgent need to find new and better ways to manage pain for people with OA. Methotrexate has been used very successfully to treat inflammation in rheumatoid arthritis. Recent studies have suggested that inflammation is also important in causing pain in osteoarthritis and therefore treating this inflammation, for example with methotrexate, has the potential to be an effective treatment for knee OA. This trial will assess the effectiveness of methotrexate in treating people with moderate to severe knee OA who are not getting benefit from traditional treatments. A pilot study in a small group of individuals has shown promising results, with 37% of participants experiencing a 40% reduction in pain, and 50% having a 20% reduction. These results now need to be confirmed in a larger, randomised trial. As well as using questionnaires to assess pain, function and use of health care, magnetic resonance images of the knee at the beginning and end of the trial will be used to see whether there are any changes in the amount of inflammation in the knee after treatment with methotrexate.

How will the findings benefit patients?

The identification of new treatments to target the pain of knee OA is critical to enable optimal management of people with this condition. If this trail has a positive outcome, methotrexate will provide a new option for people who have failed to respond to traditional treatments and for whom there are currently no further non-surgical treatment options.

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