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Study of Early versus Delayed Treatment with Azathioprine or Rituximab in Children with Anti-MOG Antibody Disease

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What is this trial about?

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

This study focuses on myelin oligodendrocytes glycoprotein antibody associated diseases (MOGAD), a condition where the immune system attacks the protective covering of nerve cells. The study will evaluate two treatment approaches in children: immediate treatment starting with the first attack versus delayed treatment starting with the second attack. The medications being tested are azathioprine, taken as tablets, and rituximab, given through an intravenous infusion. During the study, patients may also receive other medications including methylprednisolone, prednisone, and prednisolone to help manage symptoms.

The purpose of this research is to compare how well immediate versus delayed treatment works in preventing disease relapses over a 24-month period. The study will measure how often relapses occur in children who start treatment right away compared to those who start treatment after experiencing a second attack of the disease. This information will help determine the best timing for starting treatment in children with this condition.

Throughout the study period, participants will receive either azathioprine tablets taken by mouth or rituximab given through an intravenous line. The treatment will continue for 24 months, during which doctors will monitor the participants' response to the medication and track any new episodes of the disease. Various tests will be performed to assess how well the treatments are working and to monitor the participants' health status.

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

    Initial treatment phase

    You will be randomly assigned to one of three treatment groups: immediate azathioprine, immediate rituximab, or delayed treatment.

    If you are in an immediate treatment group, you will begin medication right after your first episode.

    Treatment will include methylprednisolone given through an intravenous line, followed by oral prednisone or prednisolone.

  2. Step 2

    Medication administration

    If assigned to azathioprine, you will take this medication orally.

    If assigned to rituximab, you will receive it through an intravenous line.

    If assigned to delayed treatment, you will start medication only after a second episode occurs.

  3. Step 3

    Monitoring period - first year

    Regular health assessments will track your response to treatment.

    Medical staff will monitor for any new symptoms or side effects.

    Brain imaging scans will be performed to track your condition.

  4. Step 4

    Monitoring period - second year

    Continued monitoring of your health status through regular assessments.

    Documentation of any new episodes or symptoms.

    Final evaluation at 24 months to assess treatment effectiveness.

  5. Step 5

    Study completion

    Final medical assessment after 24 months of participation.

    Review of your overall health status and treatment response.

    Completion of all required medical examinations and imaging.

Who can join the trial?

12 criteria

  • Age between 6 and 17 years old at the start of the study
  • Body weight must be 20 kilograms or more
  • Must have acute neurologic symptoms (symptoms affecting nerves or brain) that:
    • Last more than 24 hours
    • Are caused by inflammation
    • May include:
      • Eye nerve inflammation (optic neuritis)
      • Spinal cord inflammation (transverse myelitis)
      • Lower brain inflammation (rhombencephalitis)
      • Must have confirmed presence of anti-MOG antibodies (specific proteins in blood that indicate this condition)
      • No previous treatments except steroids
      • Must have a disability score (EDSS) less than 5.5 (this measures how much the condition affects daily activities)
      • Both parents and child must sign the informed consent form
      • Must have French social security coverage

Who cannot join the trial?

14 criteria

  • Age below 2 years or above 18 years
  • Previous treatment with azathioprine (a medication that suppresses the immune system)
  • Previous treatment with rituximab (a medication that affects specific immune cells called B-cells)
  • History of serious allergic reactions to any medications
  • Active or chronic infections, including tuberculosis, hepatitis B, or hepatitis C
  • Severe liver or kidney problems
  • Pregnancy or breastfeeding
  • Any condition that could interfere with the patient's ability to follow study procedures
  • Participation in other clinical trials within the past 30 days
  • Mental conditions that prevent understanding of study requirements
  • Lack of confirmed MOG antibodies (specific proteins in the blood that indicate the presence of the condition)
  • History of cancer in the past 5 years
  • Severe heart conditions
  • Known immunodeficiency disorders (conditions that weaken the immune system)
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Investigated drugs

  • Azathioprine

    is a medication that suppresses the immune system. It's commonly used to prevent the body's immune system from attacking its own tissues in autoimmune conditions. In this trial, it's being used to treat children who have a condition where antibodies attack the protective covering of nerve cells.

  • Rituximab

    is an antibody therapy that targets specific immune cells called B cells. It works by reducing the number of these cells that may be involved in attacking the nervous system. Like azathioprine, it helps control the immune system's response and is being studied as a treatment option for children with MOG antibody-associated conditions.

What is already known about the treatment

  • Azathioprine

    An oral immunosuppressive medication that works by interfering with DNA synthesis to reduce the production of immune cells, particularly affecting T and B lymphocytes. It is commonly used to prevent organ rejection in transplant patients and treat various autoimmune conditions, including myelin oligodendrocyte glycoprotein antibody-associated diseases (MOGAD). The medication is taken in tablet form daily, with the dose carefully monitored through blood tests to maintain effectiveness while minimizing side effects.

  • Rituximab

    An intravenous biologic therapy that specifically targets and depletes B cells carrying the CD20 marker, effectively reducing the immune system's ability to produce antibodies that attack healthy tissues. It is administered through scheduled infusions in a medical setting and has shown effectiveness in treating various autoimmune conditions, including MOGAD and other neurological disorders. The treatment typically involves an initial loading phase followed by maintenance doses, with careful monitoring of B cell levels throughout the treatment period.

Investigated diseases

Myelin Oligodendrocyte Glycoprotein Antibody Associated Disease (MOGAD) - A rare autoimmune condition where the body's immune system mistakenly attacks a protein called MOG, which is found on the surface of myelin sheaths in the central nervous system. The disease affects the protective covering of nerve fibers in the brain, spinal cord, and optic nerves. MOGAD can cause inflammation in different parts of the nervous system, leading to various neurological symptoms. The condition can occur as single episodes or multiple attacks over time. It commonly affects both children and adults, with symptoms that may include vision problems, weakness, numbness, and balance difficulties.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-516243-81-00Protocol codeAPHP211057Estimated enrolment86 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).