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

May 21, 2026 updated by: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

367

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • UCL Saint Luc
      • Edegem, Belgium
        • UZ Antwerpen
      • Kortrijk, Belgium
        • AZ Groeninge vzw
      • Liège, Belgium
        • Chu Sart Tilman
  • Czechia
      • Brno, Czechia
        • FN u sv. Anny Brno
      • Hradec Králové, Czechia
        • FN Hradec Králové
      • Hradec Králové, Czechia
        • NeuropsychiatrieHK
      • Ostrava, Czechia
        • Fakultni nemocnice Ostrava
      • Teplice, Czechia
        • Nemocnice Teplice
  • Greece
      • Alexandroupoli, Greece
        • University of Thrace, Medical School - Neurology Department, Alexandroupoli
      • Athens, Greece
        • Aiginiteio' Hospital
      • Athens, Greece
        • Attikon
      • Athens, Greece
        • General Miliary Hospital of Athens "401"
      • Athens, Greece
        • Evagelismos
      • Ioannina, Greece
        • University of Ioannina - Neurology department
      • Larissa, Greece
        • University Hospital of Larissa
      • Pátrai, Greece
        • University of Patras
      • Pátrai, Greece
        • General Hospital "Agios Andreas"
      • Thessaloniki, Greece
        • Interbalkan Hospital of Thessaloniki
      • Thessaloniki, Greece
        • AHEPA University Hospital of Thessaloniki
      • Thessaloniki, Greece
        • General Hospital of Athens G.Gennimatas
      • Thessaloniki, Greece
        • St Luke's Clinic
  • Netherlands
      • Sittard-Geleen, Netherlands
        • Zuyderland
  • Poland
      • Krakow, Poland
        • Oddział Kliniczny Neurologii, Szpital Uniwersytecki w Krakowie
      • Poznan, Poland
        • Medical Academy Neurology Clinic
      • Szczecin, Poland
        • Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie
  • Portugal
      • Coimbra, Portugal
        • Centro Hospitalar e Universitario de Coimbra
      • Lisbon, Portugal
        • Centro Hospitalar Universitário Lisboa Central - Hospital dos Capuchos
      • Lisbon, Portugal
        • Centro Hospitalar Lisboa Norte Hospital de Santa Maria
      • Porto, Portugal
        • Centro Hospitalar de São João E. P. E.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single cohort
This 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).
Drug: Mavenclad
This is an observational study, participants who received cladribine tablets in routine clinical practice following the SmPC will be included.
Other Names:
  • Cladribine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Discontinuation of Treatment with Cladribine tablets
Time Frame: Up to 48 months
Up to 48 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants Receiving Each of The Possible Number of Annual Treatment Courses with Cladribine Tablets
Time Frame: Baseline, 12 months, 24 months, 36 months and 48 months
Baseline, 12 months, 24 months, 36 months and 48 months
Cumulative Cladribine Dose
Time Frame: Up to 48 months
Up to 48 months
Number of Relapses
Time Frame: Baseline, 12 months, 24 months, 36 months and 48 months
Baseline, 12 months, 24 months, 36 months and 48 months
Proportion of Severe Relapses
Time Frame: Baseline, 12 months, 24 months, 36 months and 48 months
Baseline, 12 months, 24 months, 36 months and 48 months
Percentage of Participants Free From Relapse
Time Frame: Year 2 and Year 4
Year 2 and Year 4
Time From Onset of Relapse to Recovery
Time Frame: Up to Month 48
Up to Month 48
Annualized Relapse Rate (ARR)
Time Frame: At Year 2 and Year 4
At Year 2 and Year 4
Percentage of Participants Free From Magnetic Resonance Imaging (MRI) Activity
Time Frame: At Year 1, Year 2, Year 3 and Year 4
At Year 1, Year 2, Year 3 and Year 4
Percentage of Participants with Minimal MRI Activity (=< 2 New T2 Lesions)
Time Frame: At Year 1, Year 2, Year 3 and Year 4
At Year 1, Year 2, Year 3 and Year 4
Timed 25-Foot Walk (T25FW) Score
Time Frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Baseline, Year 1, Year 2, Year 3 and Year 4
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
Time Frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Baseline, Year 1, Year 2, Year 3 and Year 4
9-Hole Peg Test (9HPT) Score
Time Frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Baseline, Year 1, Year 2, Year 3 and Year 4
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
Time Frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Baseline, Year 1, Year 2, Year 3 and Year 4
Percentage of Participants With Progressed, Improved, or Stable Disability as Assessed by Expanded Disability Status Scale (EDSS) Confirmed Over 6 Months
Time Frame: Year 1, Year 2, Year 3 and Year 4
Year 1, Year 2, Year 3 and Year 4
Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by T25FW Score
Time Frame: Year 1, Year 2, Year 3 and Year 4
Year 1, Year 2, Year 3 and Year 4
Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by 9HPT Score
Time Frame: Year 1, Year 2, Year 3 and Year 4
Year 1, Year 2, Year 3 and Year 4
Percentage of Participants With Minimal Evidence of Disease Activity (MEDA)
Time Frame: Year 2 and Year 4
Year 2 and Year 4
Percentage of Participants With No Evidence of Disease Activity (NEDA-3)
Time Frame: Year 2 and Year 4
Year 2 and Year 4
Multiple Sclerosis Impact Scale (MSIS-29) Physical Domain Score, Psychological Domain Score and Total Score
Time Frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Baseline, Year 1, Year 2, Year 3 and Year 4
EuroQol 5-Dimensions (EQ-5D-5L) Score
Time Frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Baseline, Year 1, Year 2, Year 3 and Year 4
Global Satisfaction, Effectiveness, Side Effects, and Convenience Domain Scores of Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Baseline, Year 1, Year 2, Year 3 and Year 4
Treatment Cost of Disease-Modifying Treatment (DMTs)
Time Frame: Up to 48 months
Up to 48 months
EuroQol Visual Analog Scale (EQ-VAS) Score
Time Frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Baseline, Year 1, Year 2, Year 3 and Year 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2023

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS700568_0213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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