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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

Methotrexate - A disease-modifying antirheumatic drug administered via subcutaneous injection at a dosage of 15mg per week for treating erosive osteoarthritis. This medication works by inhibiting dihydrofolate reductase, which interferes with DNA synthesis and cell proliferation, helping to reduce inflammation and slow joint damage in arthritic conditions. Originally developed as a cancer treatment, methotrexate has become a widely-used medication in rheumatology and is currently being studied in clinical trials for its potential benefits in treating erosive hand osteoarthritis that hasn't responded to conventional treatments. As an immunosuppressant and antimetabolite drug, it helps control joint inflammation and prevent further erosion of joint structures.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502362-24-00Protocol code21-API-03Estimated enrolment170 patientsSponsorCentre Hospitalier Universitaire De Nice

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).