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Study on Azathioprine for Preventing Relapse in Patients with Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOG-AD) After First Attack

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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 known as Myelin Oligodendrocyte Glycoprotein Antibody Associated Disease (MOG-AD). This is a neurological disorder that affects the central nervous system, which includes the brain and spinal cord. The study aims to evaluate the effectiveness of a medication called Azathioprine in preventing relapses, or the return of symptoms, in patients who have experienced their first attack of this disease. Azathioprine is a medication that helps to suppress the immune system, which can be beneficial in conditions where the immune system mistakenly attacks the body's own tissues.

Participants in the study will be randomly assigned to receive either Azathioprine or a placebo, which is a substance with no active medication. The study will last for a maximum of three years, during which time the main goal is to see how long it takes for a relapse to occur in patients taking Azathioprine compared to those taking the placebo. Throughout the study, researchers will also monitor for any side effects related to Azathioprine and assess the overall health and quality of life of the participants.

In addition to Azathioprine, the study will also involve the use of Hydrocortisone and Prednisone, which are types of steroids that can help reduce inflammation in the body. These medications will be administered orally, meaning they will be taken by mouth. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo, to ensure unbiased results. The ultimate aim is to determine if Azathioprine can effectively prevent relapses in patients with MOG-AD, potentially offering a new treatment option for managing 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

    Joining the trial

    Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive the medication azathioprine, and the other group will receive a placebo, which is a substance with no active medication. This process is called a 'double-blind' study, meaning neither you nor the researchers will know which group you are in to ensure unbiased results.

  2. Step 2

    Medication administration

    If you are in the group receiving azathioprine, you will take the medication orally. The dosage and frequency will be determined by the study team and will be explained to you in detail. The duration of the medication administration will be up to three years, depending on your response and the study's progress.

  3. Step 3

    Regular check-ups

    Throughout the trial, you will have regular check-ups to monitor your health and any effects of the medication. These check-ups will include assessments of your overall health, any side effects, and the effectiveness of the treatment in preventing relapses of your condition.

  4. Step 4

    Monitoring for relapses

    The primary goal of the trial is to evaluate the time to the first relapse of your condition. You will be closely monitored for any signs of relapse, and this information will be used to compare the effectiveness of azathioprine against the placebo.

  5. Step 5

    End of trial assessments

    At the end of the trial period, which can last up to three years, you will undergo a series of assessments to evaluate your health status. These assessments will include measures of your disability, visual acuity, and quality of life. The results will help determine the long-term effects of the treatment.

Who can join the trial?

6 criteria

  • Must be 18 years or older.
  • Had a first attack of a condition called acute demyelinating syndrome affecting the central nervous system within the last 3 months. This can vary in severity and symptoms.
  • Tested positive for MOG-Ab, which is a specific antibody, confirmed by a specialized lab.
  • Must understand the purpose and risks of the study and be able to provide signed and dated written consent.
  • Must have health care coverage under the social security system.
  • If female and able to have children, must use effective birth control during the study and for at least three months after stopping treatment.

Who cannot join the trial?

3 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who have medical conditions outside of the field of neurology (related to the brain and nervous system).
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Azathioprine is a medication used in this clinical trial to help prevent relapses in patients with a condition called Myelin Oligodendrocyte Glycoprotein Antibody Associated Disease (MOG-AD). This condition can cause inflammation in the nervous system, leading to symptoms like vision problems, weakness, and coordination difficulties. Azathioprine works by suppressing the immune system, which can help reduce the risk of the disease flaring up again after a first attack. The trial aims to see how effective azathioprine is in preventing these relapses over a period of up to three years.

What is already known about the treatment

Azathioprine – Azathioprine is administered orally in the form of tablets. It is currently being studied in a phase 3 clinical trial to assess its effectiveness in preventing relapses in patients with Myelin Oligodendrocyte Glycoprotein Antibody Associated Disease (MOG-AD) after their first attack. This medication is primarily used in neurology for its therapeutic effects. At the molecular level, azathioprine works by interfering with the synthesis of DNA, which helps to suppress the immune system and reduce inflammation. It is classified as an immunosuppressant drug.

Investigated diseases

Neuromyelitis Optica Spectrum Disorder – Neuromyelitis Optica Spectrum Disorder is a rare autoimmune disease that primarily affects the central nervous system, particularly the optic nerves and spinal cord. It is characterized by inflammation and demyelination, which can lead to symptoms such as vision loss, muscle weakness, and paralysis. The disease often begins with episodes of optic neuritis, causing pain and vision problems, and transverse myelitis, leading to weakness or numbness in the limbs. Over time, these episodes can recur, potentially causing cumulative damage. The progression of the disease can vary, with some individuals experiencing frequent relapses and others having long periods of remission. The condition is distinct from multiple sclerosis, although they share some similar symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500520-30-00Protocol code69HCL21_1065Estimated enrolment126 patientsSponsorHospices Civils De Lyon

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