Pain Reduction in Osteoarthritis using oral Methotrexate

• Research type

  Research Study

• Full title

  An open label study to assess the effectiveness of oral methotrexate at reducing pain in knee osteoarthritis

• Contact name

  Philip Conaghan

• Sponsor organisation

  University of Leeds

• Eudract number

  2008-008237-11

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Osteoarthritis (OA) is the most prevalent joint disease and a common cause of pain and disability.Current treatments such as anti-inflammatories and steroid injections are limited by side-effects or time constraints and surgery is the only current safe long-term treatment. People with OA need further effective and safe long-term treatments. OA was traditionally thought to be a disease of cartilage and "wear and tear", but it has not been clear why OA can be so painful. However, MRI (magnetic resonance imaging) and ultrasound scans have provided new information about the pathology of OA. There is evidence from large studies to show that the synovium (lining of the joint) commonly becomes inflamed (synovitis) in OA and that this may be an important source of pain.Rheumatologists have successfully treated synovitis in conditions such as rheumatoid arthritis (RA) for years. One of the most common medications used is methotrexate, which reduces synovitis and has been shown to reduce joint swelling and pain and improve function in patients with RA. There is also good evidence for the safety and long-term use of methotrexate (up to 13 years).We propose that using methotrexate for people with painful knee OA will be an effective treatment for pain, by reducing synovitis within the knee joint. This is a 24 week trial of oral methotrexate (to a maximum of 25mg per week). Patients with OA will be identified from the rheumatology clinics of Leeds Teaching Hospitals Trust (by researchers Prof Philip Conaghan, Dr Claire Wenham or those nominated by them), screened and consented if they wish to join the study. The primary outcome of the study is change in knee pain, which will be assessed by a variety of validated questionnaires, and patients will also have ultrasound scans of their knee to assess for changes within the joint during the treatment period.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/11

• Date of REC Opinion

  26 Mar 2009

• REC opinion

  Further Information Favourable Opinion