Not yet recruitingPHASE2, PHASE3INTERVENTIONAL

Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments

This research study is investigating a medicine called methotrexate for a specific type of severe hand osteoarthritis called erosive hand osteoarthritis. This is for people whose hand pain and stiffness haven't got better with usual treatments. The study aims to see if methotrexate can help reduce further damage to the hand joints. Researchers will compare methotrexate injections with a placebo (a dummy injection that looks the same but contains no medicine) to understand its effectiveness. This is a crucial step in finding better ways to manage this painful condition, and it's currently in the later stages of testing (Phases 2 and 3), meaning it's been through initial safety checks.

At a glance

Status

Not yet recruiting

Phase

PHASE2, PHASE3

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

170

Start

02 May 2026

Estimated completion

01 Oct 2027

Erosive Hand Osteoarthritis

What is this study about?

This study is about a kind of arthritis that affects the hands, specifically called erosive hand osteoarthritis. This form of arthritis can cause significant pain and damage to the small joints in your fingers. Sometimes, standard treatments don't work well enough, and people continue to suffer from discomfort and stiffness.

Researchers are investigating whether a medicine called methotrexate, which is used for some other inflammatory conditions, could be helpful here. They want to see if it can slow down or even stop the damage to the hand joints caused by this type of osteoarthritis. This is important because finding effective treatments for those who don't respond to usual care could dramatically improve their quality of life.

The study is designed as a 'randomized' trial. This means that participants will be randomly assigned to receive either the methotrexate injection or a placebo injection (which looks exactly like the real medicine but contains no active ingredient). This helps researchers fairly compare how well methotrexate works, without anyone knowing whether they're getting the active drug or the placebo until the end of the study. This kind of research is vital for developing new and effective treatments.

Key takeaways

This study is for severe hand (erosive) osteoarthritis that hasn't responded to other treatments.
It's testing an injected medicine called methotrexate against a dummy treatment (placebo).
The goal is to see if methotrexate can reduce joint damage in the hands.
Participation involves regular clinic visits for injections and check-ups.
You must meet specific health and age criteria to be eligible (40-85 years old).
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you generally need to be between 40 and 85 years old. Your doctor would need to confirm you have osteoarthritis in your finger joints (specifically IPD and IPP joints) based on special criteria, and X-rays taken recently (within the last 3 months) should show damage in at least three of these joints. Your symptoms, like pain and stiffness, should also have been present for more than three months.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you've had certain recent injections in your hand joints (like hyaluronic acid in the last 6 months or cortisone in the last 3 months). You also couldn't take part if you have certain other medical conditions like psoriasis, inflammatory arthritis, or serious liver or kidney problems. Similarly, if you have certain infections like hepatitis B, C, HIV, or uncontrolled infections, or if you're taking specific medications like strong painkillers (morphine derivatives), certain antibiotics (Bactrim), or high doses of aspirin, you wouldn't be suitable for this study. Your doctor would carefully check all these points.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 40 and 85 years old?
Has your doctor diagnosed you with erosive osteoarthritis in your finger joints?
Have your hand pain and stiffness lasted for more than 3 months, even with other treatments?
Have you not had hyaluronic acid injections in your hand in the last 6 months, or cortisone in the last 3 months?
Are you NOT pregnant or breastfeeding and do you NOT have conditions like psoriasis, severe liver/kidney issues, or certain infections?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either methotrexate or a placebo injection. You would need to attend regular appointments for assessments, which might include check-ups, blood tests, and possibly more X-rays of your hands to monitor your condition and how you are responding to the treatment. The injections would be given as part of these visits. The study would involve a period of treatment followed by observation to see the long-term effects. The total duration of your participation would be explained in detail before you agree to join.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. You would also be contributing to medical knowledge that could help countless others with similar conditions in the future. However, there are potential risks, as with any medication, and methotrexate can have side effects. These would be fully explained to you before you consent to participate. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHU de Nice
Verified postcode
Nice, France

Common questions

What is erosive hand osteoarthritis?

It's a more severe type of hand osteoarthritis where the joint surfaces can become eroded or worn away, often causing more pain and damage than typical osteoarthritis.

What is methotrexate and how is it given?

Methotrexate is a medicine often used for inflammatory conditions. In this study, it's given as an injection, not as a tablet.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but doesn't contain any active drug. It helps researchers fairly compare the active treatment's effects.

Will I know if I'm getting the drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're receiving the methotrexate or the placebo until the study is over. This helps keep the results unbiased.

How long will the study last?

The exact duration of your participation will be fully explained by the study team, but clinical trials often last for several months or even longer.

How to find out more

Christian ROUX, Pr

roux.c@chu-nice.fr 492035512 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.