Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study.
Rheumatoid arthritis is a long-term condition that causes painful, stiff, and swollen joints. Methotrexate is the most common first-choice medicine used to treat it. In this study, researchers want to see if adding another well-known medicine called metformin works better than methotrexate on its own. Metformin is normally used to treat type 2 diabetes, but scientists believe it may also calm inflammation and protect overall health. Participants in this trial will take methotrexate alongside either metformin or a dummy tablet (placebo). Over two years, researchers will track joint swelling, pain, everyday movement, and general metabolic health, such as cholesterol and blood sugar levels. The main goal is to find out if this combination can help more people achieve low disease activity or complete remission, which could reduce the need for stronger, more complex medications in the future.
At a glance
What is this study about?
Rheumatoid arthritis happens when the immune system mistakenly attacks the lining of the joints, causing inflammation, pain, stiffness, and fatigue. Methotrexate has been the cornerstone treatment for this condition for many years. While it works well for many people, some still experience persistent symptoms or need to move on to stronger biologic therapies.
This trial, known as the METorMET² study, investigates whether combining methotrexate with metformin can offer better joint relief. Metformin is an affordable, widely used medication usually prescribed for type 2 diabetes. Early research suggests that metformin also has anti-inflammatory properties that could work hand-in-hand with methotrexate to cool down inflammation in the joints.
In addition, people with rheumatoid arthritis have a slightly higher risk of heart disease and metabolic issues. Because metformin is known to help with blood sugar and weight management, researchers hope this combined approach might support overall health alongside joint care. By comparing the combination against methotrexate with a dummy pill (placebo), the study aims to provide clear answers on whether this approach is both safe and effective.
Key takeaways
- Tests whether adding the diabetes medicine metformin to methotrexate improves rheumatoid arthritis.
- Compares the combination to methotrexate taken with a dummy pill (placebo).
- Open to adults aged 18 and over diagnosed with rheumatoid arthritis.
- Follows participants for up to two years with regular clinic check-ups and joint assessments.
- Monitors joint swelling, daily movement, and general health like weight and blood sugar.
Who may be eligible?
This clinical trial is open to adults aged 18 and over who have been diagnosed with rheumatoid arthritis. Both men and women are welcome to take part.
Because the study involves specific medicines, doctors will need to review your overall health. For example, your kidneys and liver will be checked through routine blood tests to ensure your body can handle the study medications safely.
If you are already taking certain other medications or have other significant medical conditions, the study team will discuss these with you to decide if taking part is safe and suitable for your situation.
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.
- I am aged 18 or older.
- I have been diagnosed with rheumatoid arthritis.
- I am currently taking or able to take methotrexate.
- I am willing to attend regular hospital check-ups over up to two years.
- I am happy to take study tablets every day as instructed.
What does participation involve?
If you decide to join, you will be placed into one of two groups by chance (like flipping a coin). One group will take methotrexate with metformin tablets, and the other will take methotrexate with a matching dummy pill (placebo). You may also receive folic acid to protect against side effects, and short courses of steroid tablets (prednisone) if your joints flare up. The study lasts for up to 24 months. During this time, you will attend regular hospital appointments where the team will count your swollen and tender joints, take blood and urine samples, measure your waist and weight, and ask you to fill out short questionnaires about your daily activities.
Potential risks and benefits
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Common questions
Why is a diabetes medicine being tested for arthritis?
Although metformin is best known for managing blood sugar, research shows it also has mild anti-inflammatory effects that may help reduce joint swelling and stiffness.
Will I definitely receive metformin?
No. This is a randomised trial, which means a computer randomly decides whether you receive metformin or an inactive dummy pill (placebo) alongside your methotrexate.
Will I know which treatment I am receiving?
No. Neither you nor your study doctor will know which tablet you are taking during the trial. This ensures the results are completely fair and unbiased.
Do I have to pay to take part in this study?
No. Clinical trials in the UK do not cost you anything to join, and study medications are provided free of charge. Some studies also help cover travel expenses.
What happens if my arthritis gets worse during the trial?
Your safety comes first. If your symptoms worsen, the study doctors can prescribe additional treatments, such as steroids, or adjust your care to ensure you stay comfortable.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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