Not yet recruitingPHASE4INTERVENTIONAL

Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD

This study looks at five different medicines for a rare condition called Neuromyelitis Optica Spectrum Disorder (NMOSD). NMOSD affects the eyes and spinal cord, leading to problems like vision loss and weak muscles. Researchers want to see which of these five medicines—rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab—works best to stop NMOSD flare-ups (relapses) and has the fewest serious side effects. About 160 adults with NMOSD who have a specific antibody (AQP4-IgG) will take part. They will be randomly given one of these medicines. The study will also check how the medicines affect disability, quality of life, and other health markers to help patients and doctors choose the best treatment.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Massachusetts General Hospital

Enrolment target

540

Start

01 May 2026

Estimated completion

01 May 2030

NMOSD

What is this study about?

Neuromyelitis Optica Spectrum Disorder, or NMOSD, is a rare illness where your body's defence system mistakenly attacks parts of your brain, particularly the nerves in your eyes (optic nerves) and spinal cord. This can lead to serious symptoms like losing your sight, feeling weak in your arms or legs, and severe pain. Currently, there are several medicines available that aim to stop these attacks or 'relapses' from happening. This study is designed to compare five of the most common ones: rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab.

The main goal of this research is to understand which of these treatments is most effective at preventing future NMOSD relapses and which ones have fewer serious unwanted effects. By directly comparing these medicines, doctors and patients will have clearer information to help them decide on the best treatment plan. This is really important because a treatment that works well can make a big difference to someone's daily life and slow down the progression of their condition.

In this study, around 160 adults who have been diagnosed with NMOSD and have a specific marker in their blood (called AQP4-IgG) will be asked to join. They will be carefully looked after and regularly checked to see how well the medicine is working and if they experience any side effects. This research is a crucial step towards improving the lives of people living with NMOSD.

Key takeaways

This study compares five common NMOSD treatments.
It aims to find the safest and most effective relapse-preventing medication.
Around 160 adults with AQP4-IgG positive NMOSD will participate.
Participation involves regular medical checks and specific health tests.
The study lasts 1-4 years for each participant.
Results will help improve future NMOSD treatment decisions.

Who may be eligible?

To join this study, you must be at least 18 years old and have a confirmed diagnosis of NMOSD based on specific medical guidelines. You also need to have a particular antibody in your blood called AQP4-IgG, which helps doctors understand your type of NMOSD. Importantly, you must be able to understand the study information and agree to take part, as well as be willing to follow all the study's requirements, including attending appointments and having tests.

There are also reasons why you might not be able to join. For example, if you have certain active infections like hepatitis B or C, or untreated tuberculosis, you wouldn't be eligible. If you have a known problem with your immune system or are pregnant, breastfeeding, or planning to become pregnant, you also can't take part due to safety concerns. Women who could become pregnant must agree to use effective contraception during the study and for a period afterwards.

Your doctor will also consider if any other health conditions you have might make it unsafe for you to participate or make it difficult to understand the study results. The aim is to make sure the study is safe for everyone involved and that the results are as clear and helpful as possible.

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.

Are you 18 years old or older?
Do you have a diagnosis of NMOSD?
Has your doctor confirmed you have the AQP4-IgG antibody (a specific marker for NMOSD)?
Are you able and willing to attend all study appointments and follow instructions?
Are you not pregnant, breastfeeding, or planning to become pregnant during the study?
Do you not have active infections like hepatitis B or C, or untreated tuberculosis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to receive one of the five study medications: rituximab, ravulizumab, inebilizumab, satralizumab, or eculizumab. The study involves regular check-ups with the medical team, which will include physical examinations, surveys about your health and how you feel, and specific tests like eyesight checks, walking ability assessments, and tests to look at your brain function. You'll also be asked to report any new symptoms or health problems you experience.

Throughout your time in the study, you will have various tests, including blood tests, to monitor your health and see how the medication is working. The researchers will also use these tests to look for markers that can show how active your NMOSD is. Each person will be in the study for a period ranging from one to four years, depending on how long they continue with the treatment and follow-up. All of these appointments and tests are important for understanding the full effects of the different medications.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as receiving one of the leading treatments for NMOSD and having your health closely monitored by a team of experts. The main expected benefit is to find out which treatment works best to prevent relapses and improve your quality of life. However, all medications carry potential risks, including side effects that can range from mild to serious. Your treatment will be randomly assigned, meaning you won't choose which drug you receive. You will be fully informed about the known risks of each medication before you agree to join. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Massachusetts General Hospital
Verified postcode
Boston, United States
Brigham and Women's Hospital
Verified postcode
Boston, United States
Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany

Common questions

What is NMOSD?

NMOSD stands for Neuromyelitis Optica Spectrum Disorder. It's a rare condition where your body's immune system attacks your eye nerves and spinal cord, causing problems like vision loss or weakness.

Why are there five different medicines being tested?

Doctors want to find out which of these five commonly used medicines works best to prevent NMOSD flare-ups and has the fewest side effects, to help patients and doctors make better treatment choices.

Will I get to choose which medicine I receive?

No, the medicine you receive will be chosen randomly, like drawing a name out of a hat. This helps make the study fair and scientific.

How long will I be in the study?

Each person will take part in the study for between one and four years.

What kind of tests will I have?

You'll have regular medical exams, eyesight tests, walking assessments, and tests that check brain function and how well you're doing overall.

How to find out more

Philippe-Antoine Bilodeau, MD

pbilodeau@mgh.harvard.edu 617-726-7565 Official trial record

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