Not recruiting

Study of methotrexate compared to placebo for treating pain in patients with erosive hand osteoarthritis

Registered drug

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What is this trial about?

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

This study focuses on patients with erosive hand osteoarthritis, a condition that causes pain and inflammation in the finger joints. The research aims to determine if the medication methotrexate can help reduce finger joint pain in people with this condition. This form of arthritis affects the joints in the hands, causing damage to the bone and surrounding tissues.

The study will compare methotrexate with placebo in patients who experience hand pain and symptoms. Both methotrexate and placebo will be given as tablets that participants will take by mouth. The treatment will continue for 52 weeks, during which various aspects of hand function and pain levels will be monitored.

Throughout the study, researchers will examine changes in joint pain, hand function, and daily activities. They will use various methods to assess the effectiveness of the treatment, including imaging of the hands and measurements of grip strength. The study will also track any side effects that may occur during the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your finger joint pain will be measured using a visual scale from 0 to 100
A detailed examination of your hands will be performed, including X-rays and ultrasound to assess joint condition
You will complete several questionnaires about your hand function and pain levels
Step 2
Treatment assignment
You will be randomly assigned to receive either methotrexate tablets or placebo tablets (inactive substance)
The medication or placebo will be taken by mouth
Step 3
Regular follow-up visits
You will have regular check-ups to monitor your condition
During visits, your hand pain and function will be evaluated
Additional tests will include grip strength measurements and joint examinations
Ultrasound scans will be performed to check joint inflammation
Step 4
6-month evaluation
A comprehensive assessment will be conducted at 6 months
New X-rays and magnetic resonance imaging (MRI) will be performed
Blood samples will be collected for analysis
You will complete questionnaires about pain and hand function
Step 5
12-month final evaluation
Final assessment of your condition will be performed
X-rays will be taken to evaluate changes in your joints
Final grip strength measurements will be recorded
Blood samples will be collected for final analysis

Who can join the trial?

10 criteria

Age requirement: Adults between 18 and 64 years old
Both men and women can participate
Must have finger joint pain rated between 40-80 on a scale of 0-100, where:
- Regular pain medications like paracetamol or NSAIDs (anti-inflammatory drugs) don't provide enough relief
- Or cannot tolerate these medications
- Or have medical reasons preventing use of these medications
- Must have experienced hand symptoms (pain, aching, or stiffness) on most days during the past 6 weeks
- Must meet the following medical criteria:
  - Hand osteoarthritis diagnosed according to specific medical standards (ACR criteria)
  - At least one finger joint (in fingers 2-5) showing signs of bone damage on X-ray
  - At least two finger joints showing signs of inflammation on ultrasound examination
  - Must be experiencing active inflammation in the hand joints, confirmed by ultrasound examination

Who cannot join the trial?

14 criteria

History of allergic reactions to methotrexate or similar medications
Severe kidney problems (as measured by blood tests)
Significant liver disease or abnormal liver function tests
Active or chronic infections, including tuberculosis or hepatitis
Pregnancy, breastfeeding, or planning to become pregnant
Blood disorders or significant abnormalities in blood cell counts
Current treatment with other medications that could interact with methotrexate
Other forms of arthritis that could affect the evaluation of hand symptoms
Alcohol abuse or significant daily alcohol consumption
Active stomach ulcers or other serious digestive system conditions
Participation in other clinical trials within the past 30 days
Inability to follow study procedures or attend scheduled visits
Uncontrolled high blood pressure or serious heart conditions
History of cancer within the past 5 years (except treated skin cancer)

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Investigated drugs

Methotrexate is a medication commonly used to treat various inflammatory conditions. In this trial, it is being studied for its potential to reduce pain and inflammation in hand osteoarthritis. It works by suppressing the immune system's response that causes inflammation and joint damage. This medication is already well-known for treating conditions like rheumatoid arthritis, and researchers are investigating if it can help patients with erosive inflammatory hand osteoarthritis, a particularly aggressive form of arthritis that affects the finger joints.

What is already known about the treatment

Methotrexate - A disease-modifying antirheumatic drug administered orally or by injection that is widely used in modern medicine for treating various inflammatory conditions. This medication works by interfering with cell growth and reducing inflammation by blocking the metabolism of folic acid, making it effective in treating conditions where inflammation plays a key role. Currently used in rheumatology practice, methotrexate is being investigated for its potential benefits in treating erosive hand osteoarthritis, representing a possible new application for this well-established medication. As an immunosuppressant and antimetabolite drug, it helps reduce pain and slow down joint damage by decreasing the activity of the immune system and reducing inflammation in affected tissues.

Investigated diseases

Erosive Hand Osteoarthritis - A severe form of hand osteoarthritis characterized by inflammation and breakdown of cartilage in finger joints. The condition typically affects multiple finger joints, causing progressive damage to the bone and joint structure. It leads to the formation of erosions (damaged areas) in the central portion of the finger joints, visible on X-rays. The disease usually causes pain, swelling, and stiffness in the fingers, particularly in the morning. Over time, it can result in visible deformities of the finger joints and reduced hand function.