Study of Methotrexate Treatment for Patients with Erosive Hand Osteoarthritis Not Responding to Standard Therapy

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What is this study about?

The study focuses on erosive osteoarthritis of the hands, a condition that causes joint damage and pain in the fingers. This particular form of arthritis is characterized by the breakdown of joint tissue and can significantly impact daily activities. The research aims to evaluate the effectiveness of a medication called methotrexate in treating this condition when other standard treatments have not worked well enough.

The treatment involves weekly injections of methotrexate under the skin, along with folic acid tablets to help manage potential side effects. Some participants will receive sodium chloride solution (salt water) injections instead of methotrexate. The study will last for 52 weeks, during which participants will receive regular medical check-ups to monitor their condition.

Throughout the study, doctors will track changes in the hand joints using special imaging techniques to see if the medication helps prevent further joint damage. This research is particularly important for people who continue to experience hand pain and difficulty with daily tasks despite trying other treatments for their arthritis.

1 Initial treatment phase

You will receive weekly subcutaneous injections (under the skin) of either methotrexate 15mg or placebo using a pre-filled pen

You will need to take folic acid tablets (5mg) as a supplement during the treatment

A small amount of sodium chloride solution (0.9%) will be used during the injection process

2 Treatment duration and monitoring

The treatment will continue for 12 months

Your hand joints will be regularly examined to track changes in your condition

X-rays of your hands will be taken to monitor the progress of joint changes

Ultrasound examinations will be performed to check joint inflammation

3 Assessment of treatment results

After 12 months, your hand joints will be evaluated using special scoring methods to measure changes in joint structure

The evaluation will focus on comparing the condition of your joints at the start and end of treatment

Pain levels in your hand joints will be assessed using standardized measurement tools

4 Study completion

The study will end after the final evaluation at 12 months

Your participation will conclude after completing all required assessments

The total study duration is expected to run from early 2026 to late 2028

Who Can Join the Study?

  • Must be between 40 and 85 years old
  • Must have digital osteoarthritis (affecting finger joints) that meets specific medical criteria, confirmed by:
    – An X-ray taken in the last 3 months
    – At least 3 finger joints showing signs of osteoarthritis
    – Symptoms present for more than 3 months
  • Must have at least one finger joint that shows:
    – Evidence of bone erosion on X-ray
    – Pain level greater than 40 on a pain scale
    – The pain measurement follows specific arthritis assessment guidelines (OARSI criteria)
  • Must have at least one joint showing active inflammation (synovitis) that can be seen on an ultrasound scan
  • Can be either male or female

Who Cannot Join the Study?

  • Age under 18 years or over 75 years
  • Presence of other types of arthritis besides erosive osteoarthritis
  • Current or recent treatment with methotrexate (a medication that affects the immune system)
  • Pregnancy or breastfeeding
  • Active or chronic infections
  • Severe liver disease
  • Severe kidney disease
  • History of alcohol abuse
  • Severe blood disorders
  • Active cancer or history of cancer in the past 5 years
  • Uncontrolled high blood pressure
  • Participation in other clinical trials within the past 30 days
  • Known allergic reactions to methotrexate or similar medications
  • Inability to follow study procedures or attend scheduled visits
  • Serious lung conditions

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier D’Antibes Juan Les Pins Antibes France
Centre Hospitalier De Cannes Simone Veil Cannes France
Hopital Saint Joseph Marseille France
Centre Hospitalier Universitaire De Nice Nice France
CHU Gabriel-Montpied Clermont Ferrand France
Hopital Beaujon Clichy France
Hoysmiw Hpjdd Moatqa &acxmbm 1 rce Gkkntxg Eewrkr Creteil France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
02.01.2026

Trial locations

Methotrexate is a medication that works by reducing inflammation and suppressing the immune system. It is commonly used to treat various forms of arthritis and other inflammatory conditions. In this trial, it is being studied as a potential treatment for severe hand osteoarthritis that hasn’t responded well to standard treatments. The medication is given as an injection under the skin (subcutaneously) to help reduce joint pain, swelling, and potentially slow down joint damage in patients with hand osteoarthritis.

Erosive osteoarthritis – A progressive form of osteoarthritis that primarily affects the hands, particularly the finger joints. It is characterized by inflammation and gradual breakdown of cartilage in the joints, leading to bone erosion. The condition typically causes central erosions in the finger joints, making them appear collapsed or dented in X-rays. This form of arthritis often results in joint deformity and can affect multiple fingers simultaneously. The disease typically progresses in phases, with periods of active inflammation alternating with more stable periods.

Trial ID:
2022-502362-24-00
Protocol code:
21-API-03
Trial Phase:
Therapeutic exploratory (Phase II)

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