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Study on Corticosteroids and Rituximab to Prevent Worsening of Ocular Myasthenia Gravis in Newly Diagnosed Patients

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What is this trial about?

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

This clinical trial focuses on studying a condition called ocular myasthenia gravis, which affects the muscles around the eyes, causing symptoms like drooping eyelids and double vision. The study aims to explore the effectiveness of a treatment plan that includes immediate use of corticosteroids, a type of medication that helps reduce inflammation, and the addition of rituximab, a medication that targets specific cells in the immune system, if symptoms return while reducing the corticosteroid dosage. The goal is to prevent the condition from spreading to other muscles in the body over a period of two years.

Participants in the study will receive either the treatment plan involving corticosteroids and rituximab or a different approach, which may include a placebo. The study will monitor the participants over time to see how many develop generalized myasthenia gravis, where symptoms affect more than just the eye muscles. The study will also compare the severity of symptoms, the number of hospital visits, and the quality of life between the two groups.

The medications used in this study include POLARAMINE (dexchlorpheniramine maleate), IMUREL (azathioprine), Rixathon (rituximab), PARACETAMOL PANPHARMA (paracetamol), CORTANCYL (prednisone), and SOLUMEDROL (methylprednisolone hemisuccinate). These medications are administered in various forms, such as injections or tablets, depending on the specific treatment plan. The study will last for several years, with regular check-ups to assess the effectiveness and safety of the treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm the diagnosis of ocular myasthenia gravis. This includes a clinical examination and possibly tests for anti-AChR antibodies or nerve stimulation.
Eligibility criteria include being over 18 years old, having a diagnosis within the last 6 months, and symptoms limited to ocular muscles.
Step 2
Corticosteroid therapy initiation
Immediate treatment with corticosteroids is started. The medication used is prednisone, administered orally in tablet form.
The dosage and frequency are determined by the study protocol and adjusted based on individual response.
Step 3
Monitoring and adjustment
Regular monitoring of symptoms and side effects is conducted. Adjustments to the corticosteroid dosage may be made based on symptom control and side effects.
The goal is to manage symptoms effectively while minimizing side effects.
Step 4
Rituximab administration
If ocular symptoms recur during the tapering of corticosteroids, rituximab is added to the treatment plan.
Rituximab is administered as an intravenous infusion. The frequency and duration of administration are specified in the study protocol.
Step 5
Follow-up and evaluation
Follow-up visits are scheduled to evaluate the progression of the condition and the effectiveness of the treatment.
The primary goal is to prevent the generalization of myasthenia gravis over a period of 2 years.
Step 6
Completion of trial
At the end of the trial period, a final assessment is conducted to determine the overall outcome and any long-term effects of the treatment.
The study aims to compare the outcomes between the experimental group receiving the combined treatment and a control group.

Who can join the trial?

7 criteria

Patients must be over 18 years old.
Must have been diagnosed with **ocular myasthenia** within the last 6 months. This means having eye-related symptoms like drooping eyelids (**ptosis**) or double vision (**binocular diplopia**) that change over time. The diagnosis can be confirmed by a specialist or through specific tests like positive **anti-AChR antibodies**, a decrease in response during a nerve test, or a positive **edrophonium test**.
Symptoms should be limited to the eyes or muscles around the eyes, with no other symptoms elsewhere in the body.
Must have had symptoms for at least one month to ensure it's not a more widespread form of myasthenia gravis from the start.
Should not have received any treatment that suppresses the immune system for managing ocular myasthenia gravis.
Must have received information about the study and signed a consent form agreeing to participate.
Must be affiliated with a social security system.

Who cannot join the trial?

4 criteria

Patients who have a different condition than myasthenia gravis, which is a disease that causes muscle weakness.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.
Patients who do not meet other specific criteria set by the study organizers.

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Verified sites

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Centre Hospitalier Lyon Sud
Pierre Benite, France
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Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
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Centre Hospitalier Universitaire De Lille
Lille, France

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Investigated drugs

Corticosteroids
are medications used to reduce inflammation in the body. In this trial, they are given immediately to patients diagnosed with ocular myasthenia gravis to help control symptoms and prevent the condition from worsening.
Rituximab
is a medication that targets specific cells in the immune system. In this trial, it is used if a patient's symptoms return while they are reducing their corticosteroid dosage. The goal is to prevent the disease from spreading beyond the eyes.

What is already known about the treatment

Corticosteroids
These medications are typically administered orally or intravenously and are used to reduce inflammation and suppress the immune system. In the context of myasthenia gravis, corticosteroids are employed to manage symptoms and prevent the progression of the disease. They are well-established in medical literature as a standard treatment for various autoimmune conditions. Corticosteroids work by inhibiting the production of substances that trigger inflammation, thereby reducing immune system activity. They belong to the pharmacological class of anti-inflammatory and immunosuppressive agents.
Rituximab
This medication is administered through intravenous infusion and is used in the treatment of certain autoimmune diseases and cancers. In the case of myasthenia gravis, rituximab is considered when symptoms recur during corticosteroid tapering. It is recognized in medical literature for its role in targeting specific immune cells. Rituximab works by binding to a protein on the surface of B cells, leading to their destruction and thereby reducing the immune response. It is classified as a monoclonal antibody and immunosuppressive agent.

Investigated diseases

Myasthenia Gravis – Myasthenia gravis is a chronic autoimmune disorder that affects the communication between nerves and muscles, leading to muscle weakness. It often begins with ocular symptoms such as drooping eyelids and double vision. Over time, the weakness can spread to other muscle groups, potentially affecting facial expressions, swallowing, and limb movements. The severity of symptoms can vary, with some individuals experiencing mild weakness and others facing more significant challenges. The condition is characterized by periods of exacerbation and remission, where symptoms may worsen or improve. It is important to monitor the progression of symptoms to manage the disease effectively.