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Study of Rituximab compared to placebo in patients with anti-MAG neuropathy who are likely to respond well to treatment

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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 patients with anti-MAG neuropathy, a rare nerve condition that causes weakness and numbness in the arms and legs. The condition is associated with the presence of specific antibodies that damage the protective covering of nerves. The study will test the effectiveness of rituximab, a medication that targets certain immune system cells, compared to placebo in treating this condition.

The purpose of this research is to determine if rituximab can improve neurological function in people with anti-MAG neuropathy who are likely to respond well to the treatment. The study will last 12 months, during which participants will receive either rituximab or placebo through intravenous infusion. The treatment will be given along with sodium chloride solution, which helps deliver the medication into the bloodstream.

Throughout the study, doctors will monitor changes in participants' nerve function and ability to perform daily activities. They will assess walking ability, hand function, and nerve signals to evaluate how well the treatment is working. The study will also track the levels of harmful antibodies in the blood and any side effects that may occur during treatment.

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 evaluation

    Your initial visit includes medical assessment to confirm anti-MAG neuropathy diagnosis and eligibility for the study

    Basic health measurements and neurological tests will be performed

    Blood tests will be conducted to check anti-MAG antibody levels

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either rituximab or placebo treatment

    The treatment will be administered through an intravenous infusion (directly into your vein)

  3. Step 3

    Treatment period

    The treatment involves receiving MabThera 500 mg or placebo through intravenous infusion

    A sodium chloride solution will be used during the infusion process

    Regular monitoring of your condition will occur throughout the treatment period

  4. Step 4

    Follow-up assessments

    Your progress will be monitored through several tests:

    Walking ability assessment (6-minute walk test and 25-foot walk test)

    Hand function evaluation (9-hole peg test)

    Nerve function tests (ENMG - electrical nerve and muscle testing)

    Regular blood tests to measure anti-MAG antibody levels

  5. Step 5

    Final evaluation

    After 12 months, a final comprehensive assessment will be conducted

    Your neurological disability will be measured using the I-RODS score

    The results will be compared to your initial measurements to evaluate treatment effectiveness

Who can join the trial?

10 criteria

  • Must be over 18 years old
  • Women who can become pregnant must use contraception for 1 year after receiving the study medication
  • Must have had the condition for 5 years or less with documented worsening of symptoms in the past 2 years
  • Must have a specific type of protein abnormality in the blood (IgM gammopathy)
  • Must have evidence of nerve damage shown by specific nerve testing, meeting established medical guidelines
  • Must have specific antibody levels (anti-MAG) of at least 10,000 BTU
  • Must have a minimum score of 1 point on the INCAT scale (a measure of disability)
  • Must not have received immunoglobulin treatment in the past 3 months
  • Must not have had any immunosuppressive therapy (including steroid treatment lasting 2 months or more) in the past 6 months
  • Women who can become pregnant must have a negative pregnancy test

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 80 years
  • Previous treatment with rituximab (a type of medication that affects the immune system) in the past 12 months
  • Presence of other types of neuropathy (nerve damage conditions) besides anti-MAG neuropathy
  • Active or chronic infections, including hepatitis B or C
  • History of cancer in the past 5 years
  • Severe heart, kidney, or liver disease
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • Inability to provide informed consent
  • Known allergic reactions to rituximab or similar medications
  • Severe immune system disorders other than anti-MAG neuropathy
  • Unstable medical conditions that could interfere with study participation
  • Use of immunosuppressive medications (drugs that reduce immune system activity) within the past 3 months
  • Low levels of certain blood cells that could make treatment unsafe
  • Mental health conditions that could affect ability to participate reliably in the study
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Investigated drugs

Rituximab is a medication used to treat certain autoimmune conditions. It works by targeting specific immune cells called B-cells that are involved in causing inflammation. In this trial, it is being studied for treating patients with anti-MAG neuropathy, a rare condition where the immune system attacks the nerves. The medication is given through an intravenous infusion (through a vein) and helps reduce the abnormal immune response that causes nerve damage.

What is already known about the treatment

Rituximab - A monoclonal antibody medication administered through intravenous infusion that specifically targets CD20-positive B cells in the immune system. This established therapeutic agent is widely documented in medical literature and approved for treating various autoimmune conditions, including anti-MAG neuropathy, a rare neurological disorder. Rituximab works by depleting B lymphocytes, which are responsible for producing harmful antibodies that attack the myelin sheath of peripheral nerves, and belongs to the pharmacological class of targeted immunotherapy drugs. The medication has shown promising results in clinical trials for treating patients with anti-MAG neuropathy by reducing the production of damaging antibodies and potentially improving neurological function.

Investigated diseases

Anti-MAG Neuropathy - A rare autoimmune disorder where the body's immune system produces antibodies that attack myelin-associated glycoprotein (MAG), a protein important for maintaining healthy nerve function. The condition primarily affects the peripheral nerves, causing a gradual weakening and loss of sensation that typically starts in the feet and legs, and may later affect the hands and arms. Patients experience progressive numbness, tingling sensations, muscle weakness, and difficulties with balance and coordination. The disorder usually develops slowly over months or years, mainly affecting older adults. The condition can impact daily activities such as walking, handling objects, or maintaining balance.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516335-27-00Protocol code19PH226Estimated enrolment90 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

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