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Study on Rituximab for Patients with Generalized Myasthenia Gravis

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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 Myasthenia Gravis, which is a chronic autoimmune disease that causes muscle weakness. The study aims to evaluate the effectiveness and safety of a medication called Rituximab in patients with a specific type of this disease, known as generalized AChR-antibody positive Myasthenia Gravis. Rituximab is a type of medication known as a monoclonal antibody, which is used to target and reduce certain cells in the immune system that may be contributing to the disease.

Participants in the study will receive Rituximab through an intravenous injection, which means it will be administered directly into a vein. The study will also involve the use of other medications, such as Prednisone, a corticosteroid taken orally in tablet form, and Sodium Chloride, which is a solution used for infusion. Some participants may receive a placebo instead of the active medication. The study will last for a period of up to 12 months, during which participants will have regular check-ups to monitor their health and the effects of the treatment.

The purpose of the study is to determine if Rituximab can help reduce the symptoms and improve the quality of life for people with Myasthenia Gravis. Participants will be closely monitored for any changes in their condition and any side effects they may experience. The study will also assess whether the use of Rituximab can lead to a reduction in the need for other medications, such as corticosteroids, which are commonly used to manage the symptoms of Myasthenia Gravis.

The research process

The trial runs in 6 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 required to provide written informed consent. This means you agree to participate after understanding the study's purpose and procedures.

    You will undergo initial assessments, including checking vital signs, an electrocardiogram (ECG), and laboratory tests to ensure they are within normal ranges or not clinically significant.

  2. Step 2

    Initial treatment phase

    You will begin taking prednisone, a medication administered orally. The dosage will be at least 20 mg per day, or an equivalent dose on an alternate day regimen. This will continue throughout the study.

    You will also receive rituximab through an intravenous route. The specific dosage and frequency will be determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular assessments will be conducted to monitor your condition. This includes evaluating changes in your Quantitative Myasthenia Gravis Score (QMG) and Myasthenia Gravis Activities of Daily Living (MG-ADL) score.

    You will be observed for any side effects or adverse events related to the medications.

  4. Step 4

    Mid-study evaluation

    At week 12, a detailed evaluation will be conducted to assess the changes in your condition. This includes measuring the change from baseline in your QMG and MG-ADL scores.

    Adjustments to your corticosteroid dosage may be made based on your progress.

  5. Step 5

    Continuation of treatment

    You will continue receiving the study medications, prednisone and rituximab, as per the study protocol.

    Regular follow-up visits will be scheduled to ensure your safety and to monitor the effectiveness of the treatment.

  6. Step 6

    Final evaluation

    At the end of the study, a comprehensive evaluation will be conducted to assess the overall impact of the treatment on your condition.

    The study will measure changes in your QMG and MG-ADL scores, as well as any improvements in your quality of life.

Who can join the trial?

16 criteria

  • Participants must be 18 years or older.
  • Both men and women can participate.
  • Men who are not sterilized and are sexually active with a woman who can have children must use a condom during the study and for 3 months after the last dose of the study drug. It is strongly recommended that their female partners also use a highly effective method of birth control during this time.
  • Participants must have normal vital signs (like blood pressure and heart rate), a normal electrocardiogram (ECG) which is a heart test, and normal lab test results at the start of the study, or if not normal, they must be considered not significant by the study doctor.
  • Participants must provide written informed consent and agree to data privacy rules before any study procedures are done.
  • Participants must have a diagnosis of Myasthenia Gravis (MG), confirmed by specific tests or medical history, such as:
    • A positive blood test for certain antibodies related to MG.
    • Abnormal results in tests that check nerve and muscle function.
    • A positive response to a specific medication test for MG.
    • Improvement in MG symptoms with certain medications, as assessed by a doctor.
    • Symptoms that match MG and are not explained by another condition.
    • Participants must be classified as Class II, III, or IV according to the MGFA Clinical Classification at the start of the study.
    • Participants must have an MG-ADL score of 5 or greater, with more than 50% of this score related to non-eye symptoms.
    • Participants must have a QMG score of 11 or greater at the start of the study.
    • Participants must be taking corticosteroids only, with no increase in dose within 4 weeks before starting the study, and at least 20 mg of prednisone per day (or an equivalent dose on an alternate day schedule).
    • Participants must be willing and able to follow the study protocol, complete study assessments, and attend follow-up visits.
    • Women who can have children and are sexually active with a non-sterilized male partner must use at least one highly effective birth control method from the start of the study and for 12 months after the final dose of the study drug. Methods like periodic abstinence, the rhythm method, and withdrawal are not acceptable.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have received any other treatment for Myasthenia Gravis in the last 3 months.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past 5 years, except for skin cancer that is not melanoma.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of heart disease.
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Investigated drugs

Rituximab is a medication used in this clinical trial to help treat patients with Myasthenia Gravis, a condition that causes muscle weakness. This medication works by targeting and reducing certain cells in the immune system called B lymphocytes. These cells are thought to play a role in the symptoms of Myasthenia Gravis. By reducing the number of these cells, Rituximab may help decrease the muscle weakness and improve the overall function of patients with this condition. The trial aims to see if Rituximab can effectively reduce the symptoms and improve the quality of life for patients with Myasthenia Gravis.

What is already known about the treatment

Rituximab – Rituximab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied for its effectiveness and safety in treating generalized Myasthenia Gravis, a condition that causes muscle weakness. Rituximab works by targeting and reducing specific B lymphocytes, a type of white blood cell, which are involved in the immune response that contributes to the symptoms of Myasthenia Gravis. It is classified as a monoclonal antibody, a type of medication designed to bind to specific proteins in the body to alter the immune system's activity.

Investigated diseases

Generalized Myasthenia Gravis – Generalized Myasthenia Gravis is an autoimmune disorder characterized by weakness and rapid fatigue of voluntary muscles. It occurs when the immune system produces antibodies that block or destroy muscle receptor sites for a neurotransmitter called acetylcholine. This disruption in communication between nerves and muscles leads to muscle weakness, which can vary in severity. The condition often affects muscles that control eye and eyelid movement, facial expression, and swallowing. Muscle weakness tends to worsen with activity and improve with rest. Over time, the disease can progress to involve more muscle groups, leading to generalized weakness.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518939-12-00Protocol codeREFINE_2020Estimated enrolment40 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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