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Comparing Methotrexate and Tocilizumab for Treating Giant Cell Arteritis in Patients: A Study on Effectiveness and Safety

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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 treatment of Giant Cell Arteritis (GCA), a condition that causes inflammation of the blood vessels, often leading to headaches, jaw pain, and vision problems. The study compares two treatments: Methotrexate (MTX), a medication commonly used to suppress the immune system, and Tocilizumab (TCZ), an injection that targets specific proteins involved in inflammation. Both treatments are being evaluated for their effectiveness over a period of 52 weeks.

The purpose of the study is to determine which treatment is more effective in managing GCA. Participants will receive either MTX or TCZ, along with a standard treatment of Prednisone, a type of steroid used to reduce inflammation. The study will monitor the participants' health and response to the treatments over a total of 78 weeks, with regular follow-ups to assess their condition and any side effects.

Throughout the study, the focus will be on the percentage of patients who remain in remission, meaning their symptoms are under control, without experiencing a relapse. The study will also look at the quality of life of participants, their levels of tiredness, and any side effects they may experience. The ultimate goal is to find the most effective treatment strategy for managing Giant Cell Arteritis.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient is required to provide written consent and confirm affiliation with a social security system.

    The patient must have a diagnosis of giant cell arteritis (GCA) as defined by specific criteria, including age and symptoms.

  2. Step 2

    Initial treatment phase

    The patient begins treatment with prednisone, administered orally. The dosage is adjusted based on the patient's condition and response to treatment.

    The patient may also receive tocilizumab through subcutaneous injection, depending on the treatment group assigned.

  3. Step 3

    Medication regimen

    The patient continues with a regimen that may include methotrexate and folic acid tablets, taken orally.

    The treatment aims to manage symptoms and prevent relapse over a period of 52 weeks, with follow-up extending to 78 weeks.

  4. Step 4

    Monitoring and follow-up

    The patient's health and response to treatment are monitored regularly. This includes assessing the percentage of patients alive without relapse after initial remission.

    Quality of life and tiredness are evaluated at specified intervals using standardized questionnaires.

  5. Step 5

    Completion of trial

    The trial concludes with an assessment of the patient's condition at week 78, with additional follow-up extending to 104 and 156 weeks.

    The study aims to determine the effectiveness of the treatment strategies and their impact on the patient's quality of life.

Who can join the trial?

11 criteria

  • You must provide written consent to participate in the study.
  • You need to be part of a social security system.
  • You must have a diagnosis of Giant Cell Arteritis (GCA). This is a condition that affects blood vessels, usually in the head.
  • You should be 50 years or older when the disease started.
  • You need to have a history of high levels of certain blood tests: erythrocyte sedimentation rate (ESR) of 50 mm/h or more, or C-reactive protein (CRP) of 20 mg/L or more. These tests measure inflammation in the body.
  • You must have at least one of the following symptoms: new headache, scalp tenderness, jaw pain, abnormal temporal artery, or vision loss related to blood vessel issues.
  • You may also have symptoms of polymyalgia rheumatica (PMR), which includes pain and stiffness in the shoulders or hips.
  • You need to have a temporal artery biopsy (TAB) that supports the diagnosis of GCA. This is a test where a small piece of the artery is examined for signs of the disease.
  • Alternatively, you can have evidence of large vessel vasculitis, which means inflammation of large blood vessels, shown by certain imaging tests like CT, MRI, or PET scans.
  • You must have active GCA within 6 weeks before joining the study. This means having high ESR or CRP levels and at least one symptom like a new headache, scalp tenderness, vision loss, or unexplained jaw pain.
  • Both men and women can participate in the study.

Who cannot join the trial?

3 criteria

  • Patients who have a different condition than Giant Cell Arteritis cannot participate. Giant Cell Arteritis is a condition where certain blood vessels become inflamed.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who belong to a vulnerable population, which means groups that might need special protection, are not included in this study.
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Investigated drugs

  • Methotrexate

    is a medication used to treat certain types of inflammatory conditions. In this trial, it is being tested to see how effective it is in treating giant cell arteritis, a condition that causes inflammation of the blood vessels.

  • Tocilizumab

    is another medication being studied in this trial. It is used to reduce inflammation by blocking a specific protein in the body that contributes to the inflammatory process. The trial aims to determine how well it works for patients with giant cell arteritis compared to methotrexate.

What is already known about the treatment

  • Methotrexate

    Methotrexate is typically administered orally or by injection. It is currently used in medicine for various conditions, including certain types of arthritis and cancer. In this trial, it is being studied for its effectiveness in treating Giant Cell Arteritis. Methotrexate works by inhibiting the metabolism of folic acid, which is necessary for the synthesis of DNA, RNA, and proteins, thus slowing down the growth of certain cells. It is classified as an antimetabolite and immunosuppressant.

  • Tocilizumab

    Tocilizumab is administered through intravenous infusion or subcutaneous injection. It is an established medication in the treatment of rheumatoid arthritis and is being evaluated for its use in Giant Cell Arteritis. Tocilizumab acts by blocking the interleukin-6 receptor, which plays a role in inflammation and immune response. It is classified as a monoclonal antibody and immunosuppressant.

Investigated diseases

Giant Cell Arteritis – Giant Cell Arteritis is an inflammatory disease affecting the large and medium-sized arteries, primarily in the head. It often causes headaches, scalp tenderness, jaw pain, and vision problems. The inflammation can lead to narrowing or blockage of the blood vessels, reducing blood flow. This condition is most common in older adults, particularly those over 50 years of age. If untreated, it can result in serious complications, including vision loss. The progression of the disease can vary, with periods of remission and relapse.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512269-14-00Protocol codeMETOGiAEstimated enrolment230 patientsSponsorCentre Hospitalier Universitaire De Dijon

sourced from the EU Clinical Trials Register and site verification

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