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Study on Methotrexate and Metformin for Patients with Rheumatoid Arthritis

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What is this trial about?

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

This clinical trial is focused on studying the effects of treatments for rheumatoid arthritis, a condition that causes pain and swelling in the joints. The study will compare the effectiveness of two treatments: Methotrexate alone and a combination of Methotrexate and Metformin. Methotrexate is a medication commonly used to reduce inflammation and slow the progression of rheumatoid arthritis, while Metformin is typically used to manage blood sugar levels in diabetes but is being explored here for its potential benefits in rheumatoid arthritis.

The purpose of the study is to determine if the combination of Methotrexate and Metformin is more effective than Methotrexate alone in reducing the activity of rheumatoid arthritis over a period of six months. Participants in the study will be randomly assigned to receive either the combination treatment or Methotrexate alone. Some participants may receive a placebo as part of the study design. The study will monitor the level of rheumatoid arthritis activity and other health parameters, such as weight and blood sugar levels, to assess the impact of the treatments.

Throughout the study, participants will be regularly evaluated to track their progress and any changes in their condition. The study aims to provide valuable insights into the potential benefits of combining Methotrexate with Metformin for individuals with rheumatoid arthritis, potentially leading to improved treatment options in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, rheumatoid arthritis diagnosis, and previous methotrexate use.

    A blood test is performed to ensure a negative pregnancy test for women and to check other health parameters.

  2. Step 2

    Treatment allocation

    Participants are randomly assigned to one of two groups: one receiving methotrexate alone, and the other receiving a combination of methotrexate and metformin.

    The purpose is to compare the effectiveness of these treatments in reducing rheumatoid arthritis activity.

  3. Step 3

    Medication administration

    For those in the methotrexate group, the medication is administered either orally or by injection, depending on the specific protocol.

    Participants in the combination group receive methotrexate and metformin orally. The dosage and frequency are determined by the study protocol.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor health status and treatment effectiveness. These visits include physical examinations and blood tests.

    The Disease Activity Score on 28 joints (DAS28) is used to assess rheumatoid arthritis activity.

  5. Step 5

    Evaluation of treatment response

    After 6 months, the primary evaluation of treatment response is conducted. This includes measuring the level of rheumatoid arthritis activity.

    Secondary evaluations occur at 6, 12, and 24 months, assessing remission rates, disease activity, and any need for additional treatments.

  6. Step 6

    Monitoring of side effects

    Throughout the study, any side effects or adverse events are closely monitored and recorded.

    Participants are assessed for changes in metabolic parameters, such as weight, blood sugar levels, and cholesterol.

  7. Step 7

    Completion of study

    The study is expected to conclude by December 31, 2026. Final assessments are conducted to evaluate the long-term effects of the treatments.

    Participants are provided with a summary of their health status and any necessary follow-up care is arranged.

Who can join the trial?

8 criteria

  • Patients must be over 18 years old.
  • Patients must have **rheumatoid arthritis (RA)**, which is a condition that causes pain and swelling in the joints, as defined by the **ACR 2010 criteria**. These are guidelines used to diagnose RA.
  • Patients must have a **DAS28-ESR** score greater than 3.2. This is a measure of how active the RA is, based on joint swelling and blood tests.
  • Patients must not have taken **Methotrexate** before, or if they have, it should have been more than six months ago. Methotrexate is a medication used to treat RA.
  • Men must agree to use effective birth control during the study and for six months after stopping Methotrexate. Their partners should also be informed about the potential risks of Methotrexate and use effective birth control during the study.
  • Women must have a negative pregnancy test and agree to use effective birth control during the study and for six months after stopping Methotrexate.
  • Patients must be part of a health insurance system.
  • Patients must sign a consent form, which is a document that explains the study and confirms their willingness to participate, before any study-related tests are done.

Who cannot join the trial?

10 criteria

  • Patients who have previously taken Methotrexate (MTX) cannot participate.
  • Individuals with other serious health conditions that might interfere with the study may be excluded.
  • Pregnant or breastfeeding women are not allowed to join the study.
  • Participants who are unable to follow the study procedures or attend regular check-ups may be excluded.
  • Anyone with a known allergy to Methotrexate or Metformin cannot take part in the trial.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Individuals with a history of alcohol or drug abuse may be excluded from the study.
  • People with certain mental health conditions that could affect their ability to participate may not be allowed to join.
  • Participants who have had recent surgery or are planning to have surgery during the study period may be excluded.
  • Anyone with an active infection that requires treatment may not be eligible to participate.
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Investigated drugs

  • Methotrexate

    is a medication commonly used to treat rheumatoid arthritis. It works by slowing down the immune system to help reduce inflammation and pain in the joints. In this trial, Methotrexate is being used to see how effective it is in reducing the activity of rheumatoid arthritis in patients who have not previously been treated with this medication.

  • Metformin

    is a medication typically used to treat type 2 diabetes by helping to control blood sugar levels. In this trial, Metformin is being used in combination with Methotrexate to see if it can enhance the effects of Methotrexate in reducing the symptoms of rheumatoid arthritis.

What is already known about the treatment

  • Methotrexate

    Methotrexate is typically administered orally or by injection and is widely used in the treatment of rheumatoid arthritis. It is a well-established medication in medical literature, known for its effectiveness in reducing inflammation and slowing disease progression. Methotrexate works by inhibiting the enzyme dihydrofolate reductase, which is crucial for DNA synthesis and cell replication, thereby reducing the proliferation of immune cells that contribute to inflammation. It is classified as a disease-modifying antirheumatic drug (DMARD).

  • Metformin

    Metformin is usually taken orally and is primarily known for its use in managing type 2 diabetes. However, it is being studied for its potential benefits in rheumatoid arthritis when used in combination with Methotrexate. Metformin helps improve insulin sensitivity and has anti-inflammatory properties, which may contribute to reducing disease activity in rheumatoid arthritis. It is classified as a biguanide, a type of antidiabetic medication.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the hands and feet. Over time, it can lead to joint damage and deformities. The disease may also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. It progresses through periods of flares and remissions, where symptoms can worsen or improve. The exact cause is unknown, but it involves the immune system attacking the body's own tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511033-35-00Protocol codeCHUBX 2016/44Estimated enrolment128 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

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