AuthorisedTherapeutic exploratory (Phase II)Interventional

Methotrexate treatment in hand osteoarthritis refractory to usual treatments: A randomised, double-blind, placebo-controlled trial, ADEM2 study

This study is investigating if methotrexate, a medicine often used for other conditions, can effectively treat a specific type of severe hand osteoarthritis called erosive osteoarthritis. This form of arthritis causes notable damage to the hand joints and hasn't responded to usual medical care. Participants will receive either methotrexate, a folic acid supplement (often given with methotrexate), or a salt water placebo. The main goal is to see if methotrexate can stop or slow down the worsening of joint damage over a year. The study will also look at whether the treatment improves symptoms. It's a Phase II study, meaning it’s an early step to explore how well the treatment works.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Nice

Enrolment target

170

Start

17 Oct 2025

Erosive osteoarthritis

What is this study about?

Hand osteoarthritis is a common condition where the cartilage protecting your joints wears down, causing pain, stiffness, and swelling. Some people experience a more aggressive form called erosive osteoarthritis. In this type, the bones at the ends of your joints can actually start to wear away or erode. This can lead to more severe damage and deformity in the hands, making everyday tasks very difficult. Unfortunately, for some people, the usual treatments like pain relievers, anti-inflammatory gels, or physical therapy don't work well enough.

This study is looking at a medicine called methotrexate. While methotrexate is already used for other conditions like rheumatoid arthritis, doctors want to find out if it can also help people with this severe form of hand osteoarthritis that hasn't responded to other treatments. The main purpose is to see if this medicine can slow down the joint damage and improve symptoms over a one-year period. By understanding how methotrexate affects joint damage in erosive hand osteoarthritis, researchers hope to find a new and more effective way to manage this challenging condition.

Participants will receive either methotrexate, a related vitamin called folic acid (which helps reduce side effects of methotrexate), or a placebo. A placebo is an inactive substance that looks just like the real medicine but contains no active drug. This helps scientists compare the effects of the actual treatment against no treatment at all, ensuring the results are reliable. All participants will be closely monitored by doctors throughout the study.

Key takeaways

The study checks if methotrexate helps severe hand arthritis where other treatments haven't worked.
It focuses on slowing down joint damage in 'erosive osteoarthritis'.
You might receive methotrexate, folic acid, or a placebo.
The study lasts 12 months with clinic visits and health checks.
It aims to find a new way to manage this difficult hand condition.

Who may be eligible?

This study is looking for adults who have a specific type of hand arthritis called erosive osteoarthritis. This means your hand joints show signs of bone damage, not just regular wear and tear.

You would only be considered if your current hand arthritis treatments haven't been working well enough for you. The study needs people who are at least 18 years old. Both men and women can take part.

There will be other specific health requirements that your study doctor will check to make sure the treatment would be safe for you and that you fit the study's research goals. For example, they will need to make sure you don't have other health conditions that would make taking methotrexate unsafe.

Quick self-check

Are you 18 years old or older?
Do you have severe hand osteoarthritis that hasn't gotten better with usual treatments?
Has your doctor diagnosed you with 'erosive osteoarthritis'?
Are you able to attend clinic visits regularly for 12 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of three groups: receiving methotrexate, receiving a folic acid tablet, or receiving a placebo (a dummy medicine). You won't know which group you're in, and neither will your study doctor. The methotrexate will be given as an injection, and the folic acid and placebo will be tablets.

Over a period of 12 months, you'll have several visits to the clinic. At these visits, doctors will perform assessments, which might include taking X-rays or scans of your hands to check for changes in your joints. They will also ask about your pain and other symptoms, and take blood samples to monitor your health and how the treatment is affecting you. After the initial 12 months, there will likely be further follow-up to see how you're doing long-term. The total duration of your active participation, including follow-up, will be clearly explained by the research team.

Potential risks and benefits

Participating in this study might offer you access to a potential new treatment for your severe hand osteoarthritis that isn't currently available or proven for your condition. It could also help doctors learn more about this aggressive type of arthritis, potentially benefiting many others in the future. However, there's no guarantee the treatment will work for you, and like all medicines, methotrexate can have side effects. These can range from mild, such as nausea or tiredness, to more serious ones that your doctor will discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
France

Common questions

What is 'erosive osteoarthritis'?

It's a more severe type of hand osteoarthritis where the bones in your joints start to wear away, causing more damage and pain than regular osteoarthritis.

What is methotrexate?

Methotrexate is a medicine that helps to reduce inflammation and an overactive immune system. It's used for conditions like rheumatoid arthritis, and this study aims to see if it can help with erosive hand osteoarthritis.

What is a placebo?

A placebo is an inactive substance that looks exactly like the real medicine but contains no active drug. It helps researchers compare the real treatment against no treatment at all.

What does 'double-blind' mean?

It means neither you nor your study doctor will know whether you're receiving the active medicine (methotrexate or folic acid) or the placebo. This helps make the study results fair and unbiased.

How long will the study last?

The active treatment and assessment period will last for 12 months. There might be further follow-up after that, which the research team will explain to you.