AuthorisedTherapeutic use (Phase IV)Interventional

Effects of CLADribine tablets on the Immune Synapse, in Relapsing Multiple Sclerosis (RMS) patients_CLADIS.

This study, called CLADIS, is looking at how a treatment for Multiple Sclerosis (MS) called MAVENCLAD (cladribine tablets) works. Specifically, it's investigating how this medicine affects the specialised points where immune cells connect and communicate with each other, known as the 'immune synapse'. The study involves people with a common type of MS called Relapsing Multiple Sclerosis. Researchers want to understand if changes in how these immune cells communicate can be seen after 12 months of treatment, compared to before treatment started. They are also checking how these changes relate to improvements in MS symptoms and new areas of damage seen on brain scans.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Aristotle University Of Thessaloniki

Enrolment target

Start

17 Apr 2026

Multiple Sclerosis

What is this study about?

This study, named CLADIS, is focused on understanding how a specific medication called MAVENCLAD (cladribine tablets) works in people who have Relapsing Multiple Sclerosis (RMS). RMS is a common form of MS where symptoms come and go.

Our bodies have a natural defence system, called the immune system, which helps us fight off infections. In MS, this system mistakenly attacks healthy nerve cells. Immune cells communicate with each other through special connections, which scientists call the 'immune synapse'. This study wants to see if MAVENCLAD changes how these immune cells connect and interact. By studying these changes, researchers hope to better understand how MAVENCLAD helps people with MS and discover ways to predict who might benefit most from this treatment.

The main goal is to measure these changes in immune cell communication after 12 months of taking MAVENCLAD, comparing them to how things were before treatment. Researchers will also look at whether these changes link up with improvements in a person's MS symptoms, such as how often they have relapses, their walking ability, and what brain scans show. This is like checking if the 'rewiring' of the immune system leads to real-world benefits for patients.

Key takeaways

The CLADIS study investigates how MAVENCLAD affects the immune system in Relapsing MS.
It aims to understand how immune cell communication changes over 12 months of treatment.
Researchers will compare these changes to improvements in MS symptoms and brain scans.
The study involves adults aged 18 and over with Relapsing MS.
Participation includes regular clinic visits, blood tests, and routine MS assessments.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with Relapsing Multiple Sclerosis (RMS). This is a common form of MS where people experience periods of new or worsening symptoms, followed by recovery periods.

Both men and women can take part in this research. The most important thing is that you have RMS and are an adult. Your doctor will carefully check your full medical history and current health to make sure this study is right for you and that you meet all the specific requirements set by the researchers. They will want to ensure the treatment is suitable for your condition.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Relapsing Multiple Sclerosis (RMS)?
Are you already prescribed or about to start MAVENCLAD tablets for your MS?
Are you comfortable with regular clinic visits and some additional tests?

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

What does participation involve?

This study is looking at patients who are already prescribed MAVENCLAD (cladribine tablets) as part of their routine care for Relapsing Multiple Sclerosis. Taking part means researchers will collect information about you at different times. This will involve regular visits where blood samples might be taken to look at your immune cells. You'll also likely have tests to check your walking speed, hand dexterity, and overall disability level, similar to assessments you might already have with your MS specialist. Brain scans (MRIs) will be done to see any changes in your brain. All these assessments will be carried out over a total period of 12 months, with results being compared to measurements taken before you started the treatment.

Potential risks and benefits

Taking part in a study like this helps doctors learn more about how treatments work, which could benefit future patients with MS. For you, it provides a chance for close monitoring of your health and treatment. As MAVENCLAD is already an approved medicine, the risks are generally known and your doctor will discuss these with you comprehensively. Potential side effects are associated with the medication itself, not necessarily the study procedures, and your doctor will advise you on what to expect. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Greece

Common questions

What is Relapsing Multiple Sclerosis (RMS)?

RMS is a common type of MS where symptoms come and go, with periods of worsening symptoms (relapses) followed by recovery.

What is MAVENCLAD?

MAVENCLAD is a medicine (tablets) prescribed to treat certain types of Multiple Sclerosis by affecting your immune system.

What is an 'immune synapse'?

It's a scientific term for the special connection points where immune cells communicate with each other in your body.

How long will the study last for me?

The study will look at your progress over a period of 12 months from when you start MAVENCLAD treatment.

Will I have to pay to join the study?

No, you will not have to pay to participate in this research study.

How to find out more

Official trial record

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