AuthorisedTherapeutic confirmatory (Phase III)Interventional

Rituximab therapy in anti-MAG patients with characteristics of good responders: THERAMAG study

This study, called THERAMAG, is for adults in the UK with a specific nerve condition called anti-MAG neuropathy. Doctors are trying to find out if a treatment called rituximab, given as an infusion along with a salt water solution, can significantly improve a person's symptoms. The main goal is to see if participants feel at least 4 points better on a special disability scale (I-RODS) after 12 months. This is a Phase 3 study, meaning researchers are confident the treatment is safe and are now confirming how well it works. If it helps, it could offer a new way to manage this condition.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Saint Etienne

Enrolment target

Start

25 Oct 2024

anti-MAG neuropathy

What is this study about?

This study, named THERAMAG, is a research project looking into a treatment for a condition called anti-MAG neuropathy. This is a specific type of nerve damage that can cause problems with movement, feeling, and balance.

The main idea behind the study is to see if a medicine called rituximab (also known as MabThera) can help people feel better. Participants in the study will receive rituximab as an infusion, alongside a simple salt water solution. The researchers will be carefully checking how participants' conditions change over time, specifically looking for improvements in daily activities and how they feel.

This is a 'Phase 3' study, which means it's one of the final stages of testing a new treatment. Doctors have already learned quite a bit about rituximab and now they want to confirm if it's truly effective and safe for people with anti-MAG neuropathy. If the study shows good results, it could mean a new and important treatment option becomes available for this condition.

Key takeaways

Targets adults with anti-MAG neuropathy.
Tests rituximab (MabThera) for symptom improvement.
Measures progress using various tests over 12 months.
It's a Phase 3 study, confirming effectiveness.
Involves infusions and regular health checks.

Who may be eligible?

To be able to join this study, you need to be an adult, aged 18 years or older, with no upper age limit. Both men and women are welcome to take part.

Critically, you must have been diagnosed by a doctor with anti-MAG neuropathy. The study is specifically for people with this particular type of nerve condition.

The research team will have other specific medical requirements that you'll need to meet to ensure the study is safe and appropriate for you. If you're interested, your doctor can check all these details against your medical history.

Quick self-check

Are you 18 years old or older?
Do you have a doctor's diagnosis of anti-MAG neuropathy?
Are you able to attend regular clinic appointments?
Do you understand what taking part in a study involves?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll have regular visits to your study clinic for check-ups and to receive the study medicines, which are rituximab and a salt water solution, given as infusions. These infusions will happen at set times over the study period. You won't know if you're getting the active medicine or just the salt water, as this helps researchers compare the effects accurately.

Throughout the study, you'll have various assessments. These include tests to measure your disability and how well you can move, such as walking tests (6-minute walk, timed 25-foot walk) and hand-eye coordination tests (9-hole peg test). Doctors will also perform nerve tests (ENMG) to check your nerve function and take blood samples to measure specific markers related to your condition. You'll also be closely monitored for any side effects. The total duration of your participation in the study is 12 months.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as receiving a new treatment that might improve your condition and carefully monitored medical care. However, like all medicines, rituximab can have side effects, and some people may not respond to the treatment. There's also the chance you might receive the salt water infusion which doesn't directly treat your condition. Before you decide, the study team will explain all known risks and potential benefits specific to you. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

—
France

Common questions

What is anti-MAG neuropathy?

It's a condition where your immune system mistakenly attacks part of your nerve cells, causing problems with movement, feeling, and coordination.

What is rituximab?

Rituximab is a medicine that works by targeting specific immune cells, which helps reduce the body's attack on the nerves in this condition.

How will I know if the treatment is working?

The study will use special assessments, including disability scores and walking tests, to measure if your symptoms are improving over 12 months.

Will I have to travel for the study?

Yes, you will need to attend regular appointments at a study clinic for your infusions and assessments.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.