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Study on Methotrexate for Maintaining Remission in Patients with Giant Cell Arteritis After Initial Treatment with Tocilizumab and Glucocorticoids

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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 a condition called Giant Cell Arteritis, which is an inflammation of the blood vessels, often affecting the arteries in the head. The study is investigating the effectiveness of a medication called Methotrexate in maintaining remission, which means keeping the disease inactive, after initial treatment with other medications. Participants in the study will receive either Methotrexate or a placebo, which is a substance with no active medication, to compare the outcomes.

The purpose of the study is to evaluate how well Methotrexate works in keeping the disease from coming back after patients have been treated with medications like Tocilizumab and Glucocorticoids. These treatments are typically used to reduce inflammation and manage symptoms. The study will last for about 12 months, during which participants will be monitored for any signs of the disease returning and any side effects they might experience.

Throughout the study, participants will be asked to report on their health and any symptoms they experience. The study will also track the use of other medications like Prednisone, which is often used to manage inflammation. The goal is to understand if Methotrexate can help maintain remission and reduce the need for other medications. This research could provide valuable insights into better managing Giant Cell Arteritis and improving the quality of life for those affected by this condition.

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

    Randomization and initial assessment

    Upon joining the study, you will be randomly assigned to receive either methotrexate or a placebo. This process is called randomization and ensures that the study results are unbiased.

    An initial assessment will be conducted to confirm your current health status and ensure you meet all the necessary criteria for participation. This includes confirming that you have been in stable remission from giant cell arteritis (GCA) and have been off glucocorticoids for at least one month.

  2. Step 2

    Medication administration

    You will be required to self-administer the assigned medication, either methotrexate or placebo, via a subcutaneous injection. This means you will inject the medication under your skin using a pre-filled syringe.

    The dosage of methotrexate is 50 mg/ml, and the frequency and duration of administration will be specified by the study team. It is important to follow the instructions provided to ensure the accuracy of the study results.

  3. Step 3

    Regular follow-up visits

    Throughout the study, you will have regular follow-up visits with the study team. These visits are crucial for monitoring your health and the effectiveness of the treatment.

    During these visits, various assessments will be conducted, including checking for any signs of relapse, measuring inflammation markers, and evaluating your overall health and well-being.

  4. Step 4

    Completion of treatment period

    The treatment period lasts for 12 months. During this time, you will continue to self-administer the medication and attend follow-up visits as scheduled.

    At the end of the treatment period, a final assessment will be conducted to evaluate the outcomes of the study and your health status.

  5. Step 5

    Post-study follow-up

    After completing the treatment period, you may be asked to participate in additional follow-up assessments. These assessments help gather long-term data on the effects of the treatment.

    Your participation in these follow-up assessments is important for understanding the long-term impact of the treatment on giant cell arteritis.

Who can join the trial?

9 criteria

  • Men and women who are at least 18 years old.
  • Must provide written informed consent, meaning they agree to participate in the study after being fully informed about it.
  • Must have a diagnosis of Giant Cell Arteritis (GCA), confirmed by a doctor using specific criteria.
  • Must have been previously treated with glucocorticoids (a type of steroid medication) and tocilizumab (a medication used to treat GCA) for new or returning GCA.
  • Must have stopped taking tocilizumab as decided by their rheumatologist (a doctor specializing in joint and autoimmune diseases) as part of their standard treatment.
  • Must have been on tocilizumab therapy for at least 6 months before joining the study.
  • Must be in stable remission, meaning they have no signs or symptoms of GCA and have a normal CRP (a blood test that measures inflammation) level of less than 1 mg/dl, and have not taken glucocorticoids for at least 1 month before the study starts.
  • Must be willing and able to inject either methotrexate (a medication) or a placebo (a substance with no active medication) under the skin at the start of the study.
  • Men and women must agree to use effective contraception (methods to prevent pregnancy) unless they are not able to have children.

Who cannot join the trial?

10 criteria

  • Patients who have any other serious medical conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent infection that could affect the study results.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to the study medication.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have a history of substance abuse or alcohol dependency.
  • Patients who have been diagnosed with a mental health condition that is not well controlled.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are taking medications that might interfere with the study treatment.
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Investigated drugs

  • Methotrexate

    is a medication used in this trial to help maintain remission in patients with Giant Cell Arteritis (GCA). It works by suppressing the immune system to reduce inflammation and prevent the disease from becoming active again. Patients in the trial will take methotrexate to see if it can help keep their symptoms under control after they have initially improved with other treatments.

  • Tocilizumab

    is another medication used in this trial, which is given to patients to help induce remission in Giant Cell Arteritis. It is a type of drug known as a biologic, which targets specific parts of the immune system to reduce inflammation. Tocilizumab is used at the beginning of the treatment process to help bring the disease under control quickly.

  • Glucocorticoids

    are a type of steroid medication used in this trial to help reduce inflammation in patients with Giant Cell Arteritis. They are often used to quickly control symptoms and bring about remission. In this study, glucocorticoids are used alongside tocilizumab to help patients achieve remission before switching to methotrexate for maintenance therapy.

What is already known about the treatment

Methotrexate – Methotrexate is administered orally or by injection and is being studied for its effectiveness in maintaining remission in patients with giant cell arteritis, a condition that causes inflammation of blood vessels. Currently, methotrexate is well-documented in medical literature as a treatment for various autoimmune diseases and certain types of cancer. It works by interfering with the growth of cells, particularly those that reproduce quickly, by inhibiting an enzyme involved in DNA synthesis. Methotrexate is classified as an antimetabolite 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 begins with symptoms like headaches, scalp tenderness, jaw pain, and vision problems. As the disease progresses, it can lead to more severe complications such as vision loss or stroke if untreated. The inflammation causes the walls of the arteries to thicken, which can reduce blood flow. This condition is most commonly seen in older adults, particularly those over the age of 50. The exact cause of giant cell arteritis is not well understood, but it is believed to involve a combination of genetic and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501058-12-00Protocol codeMED3-201802Estimated enrolment40 patientsSponsorRheinische Friedrich-Wilhelms-Universitaet Bonn

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