Participants needed for study of promising drug for hand osteoarthritis

Monash University

Patients with painful hand osteoarthritis are needed to test an existing drug that showed promising results in a trial led by Monash University and Alfred Health.

Published in The Lancet in late 2023, the stage 3 trial investigated methotrexate, a low-cost, effective treatment for inflammatory joint conditions such as rheumatoid arthritis and psoriatic arthritis.

The 2023 study found that methotrexate, which has been used globally for other types of arthritis since the early 1980s, reduced symptoms in those with symptomatic hand osteoarthritis (OA).

A 20mg weekly oral dose over six months had a moderate effect in reducing pain and stiffness in patients with hand OA and inflammation. Some patients received the drug and others had a placebo.

Lead researcher Professor Flavia Cicuttini, who heads Monash University’s Musculoskeletal Unit and is The Alfred’s Head of Rheumatology, said the stage 3 trial had helped guide rheumatologists, some of whom were already using methotrexate for hand OA despite the lack of evidence.

Professor Cicuttini is now leading a stage 4 trial in which all participants will receive methotrexate to see if the benefits extend beyond six months.

“Our stage 3 findings provide an evidence-base that can inform discussions between doctors and patients about the potential use of methotrexate in their hand OA,” Professor Cicuttini said.

“We have now started an open-label trial, where those involved are aware of the treatment provided, to determine whether the effect of methotrexate extends beyond the six months seen in our study. This means all eligible patients will be offered methotrexate.

“Our aim is to determine which people with hand OA are most likely to benefit and to see whether people with reduction in pain also have less joint damage. Preliminary analyses of our data suggest that women, who we know can get a very inflammatory form of hand OA around menopause, may be a group that will benefit.”

Hand OA is a disabling condition that causes pain and affects function, impeding daily activities such as dressing and eating. It can significantly reduce quality of life. About one in two women and one in four men will experience its symptoms by the time they turn 85.

Despite the high prevalence and disease burden, until now there have been no effective medications.

The new 12-month trial needs 150 participants aged between 40-75 years with hand OA who have had pain in the hand joints for most days in the last six weeks, and have moderate hand pain now.

Participants, who must live in Victoria, will have several health checks before taking methotrexate once a week, which is standard usage, and having blood tests and safety monitoring via telehealth.

/Public Release.