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RecruitingPHASE3INTERVENTIONAL

Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders

This study is investigating a treatment called rituximab for a rare nerve condition known as anti-MAG neuropathy. This condition can cause numbness, weakness, and problems with movement. Previous studies using rituximab for this condition didn't show clear benefits for everyone. However, new research suggests that rituximab might work better for certain patients, specifically those who haven't had the condition for too long and have high levels of a specific marker in their blood. This trial aims to test rituximab in these particular patients to see if it can improve their symptoms and daily life.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrolment target
90
Start
29 Jun 2023
Estimated completion
01 Dec 2028

What is this study about?

You're looking at information about a clinical trial, which is a type of research study to test new treatments or ways of using existing treatments. This particular study is about a rare condition called anti-MAG neuropathy. If you have this condition, your body's immune system mistakenly attacks the protective coating around your nerves, called myelin. This can lead to problems like numbness, tingling, weakness, and difficulty with everyday activities.

Doctors are interested in a medicine called rituximab, which is already used for other conditions. Previous studies involving rituximab for anti-MAG neuropathy didn't clearly show that it helped everyone. However, a large study with many anti-MAG patients found that certain people seemed to respond better to rituximab. These were patients who had been diagnosed with the condition for a shorter time and had a high level of a specific marker in their blood called anti-MAG.

This new study focuses specifically on these groups of patients – those with a shorter disease duration and high anti-MAG levels. The hope is that by selecting patients who are more likely to respond, researchers can get a clearer picture of whether rituximab is an effective treatment for this specific group. They will be measuring how much the treatment improves people's daily activities and abilities.

Key takeaways

  • The study is for a rare nerve condition called anti-MAG neuropathy.
  • It's testing an existing drug, rituximab, in specific patients.
  • Emphasis is on patients with shorter disease duration and high anti-MAG levels.
  • Participants will receive either rituximab or a placebo.
  • This is a Phase 3 trial, a later stage of drug testing.
  • The aim is to see if rituximab improves daily activities and nerve function.

Who may be eligible?

To join this study, your doctor will need to check some things. You'd likely be considered if you've had anti-MAG neuropathy for five years or less, and your condition has clearly worsened in the last two years. You'll also need to have a specific type of abnormal protein in your blood, and nerve tests showing a particular kind of nerve damage.

Additionally, your anti-MAG levels in your blood need to be quite high. There are also specific rules about not having had certain other treatments recently, like immunoglobulin or strong immune-suppressing medicines. You may not be able to join if you've had a severe allergic reaction to similar medicines, have certain other health problems like serious heart, kidney, or liver conditions, or if you've been treated with rituximab before.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have I had anti-MAG neuropathy for five years or less?
  2. Has my condition worsened in the last two years?
  3. Do my blood tests show specific abnormal proteins (IgM gammopathy)?
  4. Have I had nerve tests (ENMG) confirming the type of nerve damage?
  5. Do I have high levels of anti-MAG in my blood (over 10,000 BTU)?
  6. Have I avoided certain other treatments (like immunoglobulin or strong immune suppressants) in the last few months?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic. You would either receive rituximab through a drip (infusion) or a placebo, which looks like the active drug but has no medicine in it. You wouldn't know which one you're getting, and neither would your study doctor. Before the infusion, you would also receive other medications to help prevent any reactions. The study would involve several assessments to check your nerve function, daily ability, and general health over time. There would also be follow-up appointments after your treatment period. The total duration of your involvement in the study would be determined by the study design, but generally, these trials last for several months to a couple of years.

Potential risks and benefits

There's a chance that rituximab could help improve your anti-MAG neuropathy symptoms, especially if you fit the specific patient profile this study is focusing on. However, as with any medication, there are potential side effects, which the study team will discuss with you in detail. These can range from mild to more serious and will be carefully monitored. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

  • CHU Brest - La cavale blanche
    Verified postcode
    Brest, France· Recruiting
  • CHU Grenoble - La tronche
    Verified postcode
    Grenoble, France· Recruiting
  • CHU Lille - Roger Salengro
    Verified postcode
    Lille, France· Recruiting
  • CHU Limoges - Dupuytren
    Verified postcode
    Limoges, France· Recruiting
  • HCL lyon
    Verified postcode
    Lyon, France· Recruiting
  • CHU La Timone - APHM
    Verified postcode
    Marseille, France· Recruiting
  • CHU Nancy- Hôpital central
    Verified postcode
    Nancy, France· Recruiting
  • Hôtel-Dieu et Hôpital GR Laënnec - CHU Nantes
    Verified postcode
    Nantes, France· Recruiting
  • CHU Nice - Pasteur
    Verified postcode
    Nice, France· Recruiting
  • APHP Pitié Salpêtrière
    Verified postcode
    Paris, France· Recruiting
  • APHP - Kremlin-Bicêtre
    Verified postcode
    Paris, France· Recruiting
  • CHU de Saint-Etienne
    Verified postcode
    Saint-Etienne, France· Recruiting

Common questions

What is anti-MAG neuropathy?

It's a rare nerve condition where your immune system attacks the protective covering of your nerves, leading to weakness, numbness, and tingling.

What is rituximab?

Rituximab is a medicine that targets certain immune cells. It's used for some cancers and autoimmune diseases, and doctors are testing it for anti-MAG neuropathy.

Why are they only studying some anti-MAG patients?

Previous research suggests rituximab might work better for patients who haven't had the condition for too long and have high levels of a specific marker called anti-MAG.

Will I get the real drug or a dummy drug?

In this type of study, you have a chance of getting either the active drug (rituximab) or a 'placebo' (dummy drug). Neither you nor your doctor will know which one you receive.

What's a 'phase 3' trial?

This means it's a later stage of research, where the treatment has already shown promise in earlier studies and is now being tested on more people to confirm its safety and effectiveness.

How to find out more

Anne-Laure KAMINSKY, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Rituximab Therapy in Anti-Myelin Associated Glycoprotein Pat…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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