Not yet recruiting

Effect of cladribine tablets on immune synapse in patients with relapsing multiple sclerosis

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Multiple Sclerosis (MS) is a condition in which the body’s own immune system mistakenly attacks the protective covering of nerve fibers, causing problems such as muscle weakness, vision changes, and fatigue. In the relapsing form of the disease, symptoms can improve and then return again. The study uses oral tablets called MAVENCLAD that contain the active ingredient cladribine, which works by reducing the activity of certain immune cells that are involved in the disease.

The purpose of the study is to see how the drug changes the communication points between immune cells, known as the immune synapse, after one year of treatment compared with people who do not have the disease. Participants will take the tablets as directed for up to a year and will attend regular visits where blood samples are collected and simple tests are performed, such as a walk test, a hand‑function test, and a disability rating called the EDSS (a scale that measures how MS affects daily activities). At the start and after six and twelve months, brain scans using MRI will be done to look for changes in lesions, and the results will be compared with baseline measurements.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial enrollment
patient signs the consent form and becomes a participant in the study.
Baseline data are collected, including medical history, neurological examination, and magnetic resonance imaging.
Step 2
Start of medication
mavenclad 10 mg tablets are taken by mouth.
The prescribed dose is 20 mg per day, usually taken as two 10 mg tablets.
The medication is taken daily for the duration of the 12‑month treatment period.
Step 3
Early safety monitoring
Blood tests and physical examinations are performed during the first weeks to check for any adverse effects.
Any side effects are recorded and reported to the study team.
Step 4
6‑month assessment
At month six, a follow‑up visit is scheduled.
The same evaluations as at baseline are repeated, including blood work, neurological assessment, and imaging.
The primary laboratory measurements focus on changes in immune‑synapse molecules compared with the baseline values.
Step 5
12‑month assessment and trial completion
At month twelve, the final study visit occurs.
All baseline examinations are repeated again.
The primary outcome, which is the change in immune‑synapse molecules after 12 months of treatment, is measured.
Secondary outcomes such as relapse rate, disability scores, walking speed, hand function, and brain lesions are also evaluated.
The study medication is stopped after the 12‑month period.
Step 6
Post‑study follow‑up
After the trial ends, the participant may be offered routine clinical follow‑up according to standard care guidelines.
No additional study procedures are required beyond the 12‑month visit.

Who can join the trial?

7 criteria

Age between 18 and 50 years – you must be at least 18 years old but not older than 50.
Having relapsing‑remitting multiple sclerosis (RRMS) – a form of MS that involves episodes of worsening symptoms followed by periods of recovery.
Being treatment naïve – you have not taken any disease‑modifying medicines for MS before joining the study.
Prescribed cladribine – your doctor must decide to give you this medication according to the official prescribing guide (the SmPC) approved for use in Greece.
No other neurological disease – you must not have any additional brain or nerve disorders besides MS.
Willing and able to sign a written informed consent – you agree in writing to take part after understanding what the study involves.
Completed a full diagnostic workup for MS within the last 6 months – you must have had all the necessary tests and examinations confirming your MS diagnosis during the previous half‑year.

Who cannot join the trial?

7 criteria

If the medication guide for cladribine tablets lists reasons (called contraindications) why you should not take this drug, you cannot join the study.
If you have a history of alcohol or drug abuse that might affect how you take part in the study, you cannot join.
If you are already taking part in another research trial (an investigational study) where the plan (the protocol) controls what tests or treatments you receive, you cannot join.
If you are younger than 18 years old or older than 50 years old, you cannot join.
If you have a type of multiple sclerosis that continuously gets worse over time (called progressive MS), you cannot join.
If you have used or are currently using other medicines that treat multiple sclerosis (called disease‑modifying therapies or DMTs), you cannot join.
If your multiple sclerosis was diagnosed more than 6 months before you would be included in the study, you cannot join.

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Investigated drugs

MAVENCLAD tablets are taken by mouth and contain the medicine cladribine. In this study, the tablets are given to people with relapsing multiple sclerosis to see how the drug changes certain molecules that help immune cells talk to each other. Researchers want to find out if cladribine can modify the immune system in a way that could be helpful for treating the disease.

Cladribine

What is already known about the treatment

MAVENCLAD 10 mg tablets - It is taken as a tablet by mouth, usually in short courses of treatment. Cladribine is an approved medicine for relapsing forms of multiple sclerosis and is well described in medical literature as a disease‑modifying therapy. It works by gently lowering the activity of certain immune cells that mistakenly attack the nervous system, helping to reduce attacks and slow progression. It belongs to the class of purine nucleoside analogues, a type of drug that influences immune cell growth.

Investigated diseases

Multiple Sclerosis - Multiple Sclerosis is a chronic disease of the nervous system in which the immune system mistakenly attacks the protective covering of nerve fibers. This damage interferes with the flow of information between the brain and the rest of the body, causing new or worsening symptoms over time. The condition often follows periods of activity and remission, with symptoms gradually accumulating as more nerve tissue is affected.