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Multiple SclerosisNCT05797740

Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)

An observational study of Multiple Sclerosis, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 30 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Mavenclad
Type of treatment
Pill or oral medicine
How many people
366 participants
Where
30 sitesin 6 countries
Study dates
3 Aug 2023to 31 Jan 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

30 sites in 6 countries.

30 sites in 6 countries

Greece13 sites

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

    Alexandroupoli

  • Aiginiteio' Hospital

    Athens

  • Attikon

    Athens

  • Evagelismos

    Athens

  • General Miliary Hospital of Athens "401"

    Athens

  • University of Ioannina - Neurology department

    Ioannina

  • University Hospital of Larissa

    Larissa

  • General Hospital "Agios Andreas"

    Pátrai

  • University of Patras

    Pátrai

  • AHEPA University Hospital of Thessaloniki

    Thessaloniki

  • General Hospital of Athens G.Gennimatas

    Thessaloniki

  • Interbalkan Hospital of Thessaloniki

    Thessaloniki

  • St Luke's Clinic

    Thessaloniki

Other trials in Greece

Czechia5 sites

  • FN u sv. Anny Brno

    Brno

  • FN Hradec Králové

    Hradec Králové

  • NeuropsychiatrieHK

    Hradec Králové

  • Fakultni nemocnice Ostrava

    Ostrava

  • Nemocnice Teplice

    Teplice

Other trials in Czechia

Belgium4 sites

  • UCL Saint Luc

    Brussels

  • UZ Antwerpen

    Edegem

  • AZ Groeninge vzw

    Kortrijk

  • CHU Sart Tilman

    Liège

Other trials in Belgium

Portugal4 sites

  • Centro Hospitalar e Universitario de Coimbra

    Coimbra

  • Centro Hospitalar Lisboa Norte Hospital de Santa Maria

    Lisbon

  • Centro Hospitalar Universitário Lisboa Central - Hospital dos Capuchos

    Lisbon

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

    Porto

Other trials in Portugal

Poland3 sites

  • Oddział Kliniczny Neurologii, Szpital Uniwersytecki w Krakowie

    Krakow

  • Medical Academy Neurology Clinic

    Poznan

  • Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie

    Szczecin

Other trials in Poland

Netherlands1 site

  • Zuyderland

    Sittard-Geleen

Other trials in Netherlands

About this study

This study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple sclerosis (RMS) in the long term, in a real-world setting.

Being tested
Mavenclad
Keywords
Multiple Sclerosis, Relapsing Multiple Sclerosis, Mavenclad, Cladribine Tablets
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MavencladDrug

    Also called Cladribine

    This is an observational study, participants who received cladribine tablets in routine clinical practice following the SmPC will be included.

Study groups in NCT05797740
Study groupRoleWhat they receive
Single cohortThis is a single cohort study enrolling Participants with relapsing multiple sclerosis (RMS), who are prescribed treatment with cladribine tablets in routine clinical practice following the summary of product characteristics (SmPC).
Receives: Drug: Mavenclad

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Discontinuation of Treatment with Cladribine tablets

    Measured: Up to 48 months

Secondary outcomes (23)

  1. Percentage of participants Receiving Each of The Possible Number of Annual Treatment Courses with Cladribine Tablets

    Measured: Baseline, 12 months, 24 months, 36 months and 48 months

  2. Cumulative Cladribine Dose

    Measured: Up to 48 months

  3. Number of Relapses

    Measured: Baseline, 12 months, 24 months, 36 months and 48 months

  4. Proportion of Severe Relapses

    Measured: Baseline, 12 months, 24 months, 36 months and 48 months

  5. Percentage of Participants Free From Relapse

    Measured: Year 2 and Year 4

  6. Time From Onset of Relapse to Recovery

    Measured: Up to Month 48

  7. Annualized Relapse Rate (ARR)

    Measured: At Year 2 and Year 4

  8. Percentage of Participants Free From Magnetic Resonance Imaging (MRI) Activity

    Measured: At Year 1, Year 2, Year 3 and Year 4

  9. Percentage of Participants with Minimal MRI Activity (=< 2 New T2 Lesions)

    Measured: At Year 1, Year 2, Year 3 and Year 4

  10. Timed 25-Foot Walk (T25FW) Score

    Measured: Baseline, Year 1, Year 2, Year 3 and Year 4

  11. Percentage of Participants with an Increase and Decrease in Timed 25-Foot Walk (T25FW) Score of At Least 20% From Baseline at Year 1, 2, 3 and 4

    Measured: Baseline, Year 1, Year 2, Year 3 and Year 4

  12. 9-Hole Peg Test (9HPT) Score

    Measured: Baseline, Year 1, Year 2, Year 3 and Year 4

  13. Percentage of Participants with an Increase and Decrease in 9-Hole Peg Test (9HPT) Score of At Least 20% From Baseline at Year 1, 2, 3 and 4

    Measured: Baseline, Year 1, Year 2, Year 3 and Year 4

  14. Percentage of Participants With Progressed, Improved, or Stable Disability as Assessed by Expanded Disability Status Scale (EDSS) Confirmed Over 6 Months

    Measured: Year 1, Year 2, Year 3 and Year 4

  15. Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by T25FW Score

    Measured: Year 1, Year 2, Year 3 and Year 4

  16. Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by 9HPT Score

    Measured: Year 1, Year 2, Year 3 and Year 4

  17. Percentage of Participants With Minimal Evidence of Disease Activity (MEDA)

    Measured: Year 2 and Year 4

  18. Percentage of Participants With No Evidence of Disease Activity (NEDA-3)

    Measured: Year 2 and Year 4

  19. Multiple Sclerosis Impact Scale (MSIS-29) Physical Domain Score, Psychological Domain Score and Total Score

    Measured: Baseline, Year 1, Year 2, Year 3 and Year 4

  20. EuroQol 5-Dimensions (EQ-5D-5L) Score

    Measured: Baseline, Year 1, Year 2, Year 3 and Year 4

  21. Global Satisfaction, Effectiveness, Side Effects, and Convenience Domain Scores of Treatment Satisfaction Questionnaire for Medication (TSQM)

    Measured: Baseline, Year 1, Year 2, Year 3 and Year 4

  22. Treatment Cost of Disease-Modifying Treatment (DMTs)

    Measured: Up to 48 months

  23. EuroQol Visual Analog Scale (EQ-VAS) Score

    Measured: Baseline, Year 1, Year 2, Year 3 and Year 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start3 Aug 2023
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797740
Sponsor's protocol ID
MS700568_0213
Status last verified
Oct 2026
First submitted
22 Mar 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 30 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Greece, Czechia, Belgium, Portugal, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Discontinuation of Treatment with Cladribine tablets (time frame: Up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05797740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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