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Study on Cladribine for Treating Seropositive Myasthenia Gravis in 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 is focused on studying the disease known as Myasthenia Gravis, a condition that causes weakness in the muscles that control voluntary movements. The trial is investigating the use of a medication called Cladribine, which is being added to the current treatment plan for patients with a specific type of this disease, known as seropositive myasthenia gravis. The purpose of the study is to evaluate how effective and safe Cladribine is when used in combination with existing treatments.

Participants in the study will receive either Cladribine or a placebo, in addition to their regular treatment. The study will take place over several weeks, during which participants will have regular visits to monitor their health and the effects of the treatment. These visits will include assessments of how the disease affects daily activities and whether there is a need for additional treatments. The study will also look at changes in certain blood markers related to the disease.

Throughout the trial, the safety of the participants will be closely monitored, with regular checks on various health parameters such as blood counts and liver function. The study aims to provide valuable information on whether adding Cladribine to the treatment plan can help improve the management of Myasthenia Gravis and reduce the need for other medications like steroids. The trial is expected to continue until 2026, with the goal of improving treatment options for those affected by 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.

Step 1
Initial visit and baseline assessment
Upon joining the study, an initial visit is conducted to assess your current health status. This includes a review of your medical history and a physical examination.
Baseline tests are performed, including blood tests and imaging studies, to establish your health status before starting the trial.
Step 2
Randomization and start of treatment
You will be randomly assigned to receive the study medication, cladribine, or a placebo. This process is called randomization.
The medication is administered through a subcutaneous injection, which means it is injected under the skin.
Step 3
Treatment phase
During the treatment phase, you will receive cladribine injections at specified intervals. The exact dosage and frequency will be explained to you by the study team.
Regular visits are scheduled to monitor your response to the treatment and to check for any side effects.
Step 4
Efficacy and safety assessments
Throughout the trial, assessments are conducted to evaluate the effectiveness of the treatment. This includes measuring changes in your symptoms and daily living activities.
Safety assessments are also performed to monitor for any adverse effects. These include blood tests and other health evaluations.
Step 5
Follow-up visits
After completing the treatment phase, follow-up visits are scheduled to continue monitoring your health and the long-term effects of the treatment.
These visits help ensure your well-being and provide additional data for the study.

Who can join the trial?

13 criteria

Must be over 18 years old.
Must have a confirmed diagnosis of myasthenia gravis, a condition that affects the muscles.
Must have tried other treatments without success, including specific medications and steroids, which are drugs that reduce inflammation.
If not on any treatment, must not want to use steroids due to side effects.
Must agree to participate by signing a consent form.
Must have a specific pattern of muscle weakness that changes during the day.
Must have certain antibodies in the blood that are linked to myasthenia gravis. Antibodies are proteins made by the immune system.
Must have information about the thymus gland, either from a chest scan or from surgery if the thymus was removed. The thymus is a gland in the chest.
Must have a stable dose of steroids for at least 4 weeks before starting the trial.
Must not have used other immune system-affecting drugs for at least 4 weeks before starting the trial.
Must have a stable dose of acetylcholinesterase inhibitors for at least 4 weeks before starting the trial. These are drugs that help improve muscle strength.
Must have a test result showing muscle response, either from the past 5 years or done at the start of the trial.
Must have a brain MRI scan result, either from the past 5 years or done at the start of the trial. An MRI is a type of scan that uses magnets and radio waves to create images of the inside of the body.

Who cannot join the trial?

8 criteria

Patients who do not have a confirmed diagnosis of myasthenia gravis cannot participate. Myasthenia gravis is a condition that causes weakness in the muscles.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are taking medications that might interfere with the study cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who have a history of allergic reactions to the study medication cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Pomeranian Medical University
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Szczecin, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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Cracow, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
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Poznan, Poland

Trial locations

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Investigated drugs

Cladribine is a medication being tested in this clinical trial to see if it can help people with a condition called seropositive myasthenia gravis. This condition affects the muscles, making them weak and tired. Cladribine is thought to work by affecting the immune system, which might help reduce the symptoms of muscle weakness. The trial is looking at how safe and effective cladribine is when added to the usual treatment for this condition.

Cladribine

What is already known about the treatment

Cladribine – Cladribine is administered orally in the form of tablets. It is currently being studied in a phase 2 clinical trial to assess its effectiveness and safety when added to existing treatments for seropositive myasthenia gravis, a condition that causes muscle weakness. The main therapeutic indication for cladribine in this trial is to help manage myasthenia gravis. At the molecular level, cladribine works by interfering with the DNA synthesis of certain immune cells, which helps reduce their activity and can lead to improved muscle function. It is classified as an immunosuppressant, meaning it helps to dampen the immune system's activity.

Investigated diseases

Myasthenia gravis – Myasthenia gravis is a chronic autoimmune neuromuscular disorder characterized by weakness and rapid fatigue of voluntary muscles. It occurs when the immune system mistakenly attacks the communication between nerves and muscles, leading to muscle weakness. 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 severity of symptoms can fluctuate, with periods of improvement and worsening. The disease can progress to involve more muscle groups, potentially affecting breathing and limb movements.