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Study on Stopping Tocilizumab for Patients with Giant Cell Arteritis

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

This clinical trial is focused on studying Giant Cell Arteritis, a condition that causes inflammation of the blood vessels, often in the head. The study will explore the effects of stopping treatment with tocilizumab, a medication used to manage this condition. Tocilizumab is administered as a solution for injection, either in a pre-filled pen or syringe, and is known by other names such as RoActemra and RO4877533.

The purpose of the study is to compare two different approaches to discontinuing tocilizumab: stopping it immediately or gradually over 24 weeks. Participants will be monitored for 26 weeks to see how well they do without the medication, focusing on whether they remain free from relapses, which are returns of disease symptoms. The study will also look at the overall health and quality of life of participants during this period.

Participants will receive either the immediate or gradual discontinuation strategy and will be followed up with regular check-ins to assess their health status. The study aims to provide insights into the best way to stop tocilizumab treatment while minimizing the risk of relapse and maintaining the well-being of individuals with 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, you will be randomly assigned to one of two groups. One group will stop taking the medication tocilizumab immediately, while the other group will gradually reduce the dosage over 24 weeks.

  2. Step 2

    Medication administration

    If you are in the gradual discontinuation group, you will continue to receive tocilizumab as a subcutaneous injection. The dosage is 162 mg, administered once a week. This will continue for up to 24 weeks, depending on your group assignment.

  3. Step 3

    Follow-up visits

    You will have regular follow-up visits to monitor your health and the effectiveness of the treatment. These visits will occur at weeks 0, 12, 26, 52, and 78. During these visits, various assessments will be conducted, including quality of life evaluations and fatigue scoring.

  4. Step 4

    Monitoring and assessments

    Throughout the study, your health will be closely monitored. This includes checking for any signs of relapse or side effects. Blood tests and imaging may be performed to assess your condition and the impact of the treatment.

  5. Step 5

    End of study

    The study will conclude after 78 weeks. At this point, a final assessment will be conducted to evaluate your health status and the overall outcomes of the treatment strategy you followed.

Who can join the trial?

18 criteria

  • Provide written consent to participate in the study.
  • Have stopped treatment with corticoids (a type of steroid medication) at least 12 weeks before joining the study. However, taking hydrocortisone (up to 20 mg per day) is allowed if the dose remains stable during the study.
  • Have a recent blood test (within 6 weeks) showing good tolerance to tocilizumab, a medication used in the study. The test should show:
    • AST and ALT (liver enzymes) less than 1.5 times the upper limit of normal.
    • Hemoglobin (a protein in red blood cells) greater than 8 g/dL.
    • Platelets (cells that help with blood clotting) greater than 100 G/L.
    • Neutrophils (a type of white blood cell) greater than 1 G/L.
    • Lymphocytes (another type of white blood cell) greater than 0.5 G/L.
    • Have a diagnosis of Giant Cell Arteritis (GCA), confirmed by:
      • Being at least 50 years old at the time of diagnosis.
      • Having a history of high ESR (a blood test that measures inflammation) of 50 mm/h or more, or high CRP (another inflammation marker) of 20 mg/L or more. This criterion is optional if a temporal artery biopsy is positive.
      • Having at least one clear sign of GCA, such as a recent headache, scalp tenderness, jaw pain when chewing, abnormal temporal artery, or vision problems due to lack of blood flow.
      • Having clinical signs of polymyalgia rheumatica (a condition causing muscle pain and stiffness).
      • Having evidence of GCA during follow-up, such as:
        • A temporal artery biopsy showing specific signs of GCA.
        • Evidence of inflammation in the temporal arteries using an echo-Doppler test.
        • Evidence of inflammation in large blood vessels using imaging tests like angio-CT, angio-MRI, or PET scan.
        • Have GCA in remission (no symptoms and CRP of 10 mg/L or less) for at least 12 weeks before joining the study.
        • Have been treated with tocilizumab (TCZ) or a similar medication, either through an IV (intravenous) or SC (subcutaneous) method, for 12 to 36 months before joining the study.
        • Have not stopped TCZ treatment for more than 12 weeks in the 12 months before joining the study.
        • Have been receiving subcutaneous TCZ (162 mg per week) or a similar medication for at least 12 consecutive weeks before joining the study.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have received any other investigational drug within the last 30 days.
  • Patients with a history of severe allergic reactions to any medication.
  • Patients with a history of cancer, except for certain types of skin cancer that have been treated.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients who have been vaccinated with a live vaccine within the last 4 weeks.
  • Patients who have a history of alcohol or drug abuse.
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Investigated drugs

Tocilizumab is a medication used in this clinical trial. It is designed to help reduce inflammation in the body. In this study, the researchers are looking at how stopping the use of tocilizumab affects people with a condition called Giant Cell Arteritis, which causes inflammation of the blood vessels. The trial is comparing two different ways of stopping the medication: one where it is stopped immediately and another where it is gradually reduced over a period of time. The goal is to see which method is better at preventing the condition from coming back.

What is already known about the treatment

Tocilizumab – Tocilizumab is administered as an injection, typically given under the skin or directly into a vein. It is currently being studied for its effectiveness in treating Giant Cell Arteritis, a condition that causes inflammation of blood vessels. The medication works by blocking a specific protein in the body called interleukin-6 (IL-6), which plays a role in inflammation. Tocilizumab is classified as an immunosuppressive drug, meaning it helps reduce the activity of the immune system to decrease inflammation.

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 affected arteries, reducing blood flow. Over time, this can result in complications such as vision loss or stroke if not managed. The disease is more common in older adults, particularly those over 50 years of age. It progresses with episodes of active inflammation and periods of remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505515-21-00Protocol codeMAGICAEstimated enrolment120 patientsSponsorCentre Hospitalier Universitaire De Dijon

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