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Can we predict who will benefit from cladribine? new study aims to find out

NCT ID NCT05797740

Knowledge-focused Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This observational study follows 367 adults with relapsing multiple sclerosis who are taking cladribine tablets (Mavenclad) in routine care. Researchers want to find out which patient characteristics predict how long people stay on the drug and how well it works. The goal is to help doctors personalize treatment decisions for MS.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cladribine tablets (Mavenclad)
What this could lead to
If successful, this study could help doctors identify which multiple sclerosis patients are most likely to benefit from cladribine tablets, leading to more personalized treatment decisions.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection and real-world variability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

366 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study enrolls participants with a confirmed diagnosis of RMS (with high disease activity) who have been prescribed, have initiated, or have completed/discontinued treatment with cladribine tablets per the decision of the treating physician.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult participants, male or female patients ≥ 18 years old at index date * Participants must voluntarily give written informed consent form (ICF). Patients must read and fully understand the ICF * Participants with confirmed diagnosis of RMS at index date, diagnosed by the treating physician according to applicable clinical practice guidelines (currently McDonald 2017 criteria), with high disease activity. * Required historical data should be available: number of relapses in the 12 months prior to index date, DMTs taken prior to index date, date of MS diagnosis, and data of at least 1 MRI prior to index date as specified in the drug Summary of Product Characteristics (SmPC) * Fulfillment of the indication for treatment with cladribine tablets at index date, per standard of care in accordance with the local SmPC * Meeting 1 of the following criteria: * Prospective participants: Having been prescribed with cladribine tablets or having taken at least one dose of cladribine tablets, with enrollment date prior to the second treatment week * Retrospective participants: Having taken at least one dose of cladribine tablets, with enrollment date during or after the second treatment week but not more than 3 years after the first dose of cladribine tablets Exclusion Criteria: * Contraindications to use of cladribine tablets according to the SmPC. * Any participant who had the first dose of cladribine tablets more than 3 years prior to enrollment * Any participant who is pregnant or plans to breast-feed while taking cladribine tablets, or any patient who or whose partner plans to become pregnant in Year 1 or within 6 months after the last dose in Year 2, or any participants who is unwilling or unable to use contraception per the SmPC * Have participated or participating in an interventional study since cladribine tablet initiation, in which participant assessment and/or treatment may be dictated by a protocol * Participants who, at the discretion of the Investigator, will not be able to provide reliable information for the study

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • AHEPA University Hospital of Thessaloniki

    Thessaloniki, Greece

  • AZ Groeninge vzw

    Kortrijk, Belgium

  • Aiginiteio' Hospital

    Athens, Greece

  • Attikon

    Athens, Greece

  • CHU Sart Tilman

    Liège, Belgium

  • Centro Hospitalar Lisboa Norte Hospital de Santa Maria

    Lisbon, Portugal

  • Centro Hospitalar Universitário Lisboa Central - Hospital dos Capuchos

    Lisbon, Portugal

  • Centro Hospitalar de São João E. P. E.

    Porto, Portugal

  • Centro Hospitalar e Universitario de Coimbra

    Coimbra, Portugal

  • Evagelismos

    Athens, Greece

  • FN Hradec Králové

    Hradec Králové, Czechia

  • FN u sv. Anny Brno

    Brno, Czechia

  • Fakultni nemocnice Ostrava

    Ostrava, Czechia

  • General Hospital "Agios Andreas"

    Pátrai, Greece

  • General Hospital of Athens G.Gennimatas

    Thessaloniki, Greece

  • General Miliary Hospital of Athens "401"

    Athens, Greece

  • Interbalkan Hospital of Thessaloniki

    Thessaloniki, Greece

  • Medical Academy Neurology Clinic

    Poznan, Poland

  • Nemocnice Teplice

    Teplice, Czechia

  • NeuropsychiatrieHK

    Hradec Králové, Czechia

  • Oddział Kliniczny Neurologii, Szpital Uniwersytecki w Krakowie

    Krakow, Poland

  • St Luke's Clinic

    Thessaloniki, Greece

  • Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie

    Szczecin, Poland

  • UCL Saint Luc

    Brussels, Belgium

  • UZ Antwerpen

    Edegem, Belgium

  • University Hospital of Larissa

    Larissa, Greece

  • University of Ioannina - Neurology department

    Ioannina, Greece

  • University of Patras

    Pátrai, Greece

  • University of Thrace, Medical School - Neurology Department, Alexandroupoli

    Alexandroupoli, Greece

  • Zuyderland

    Sittard-Geleen, Netherlands

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