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NCT Number: NCT05797740

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCL Saint Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mavenclad

Drug

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

Other names: Cladribine

Primary outcomes

  1. Time to Discontinuation of Treatment with Cladribine tablets

    Time frame: Up to 48 months

Secondary outcomes

  1. 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

  2. Cumulative Cladribine Dose

    Time frame: Up to 48 months

  3. Number of Relapses

    Time frame: Baseline, 12 months, 24 months, 36 months and 48 months

  4. Proportion of Severe Relapses

    Time frame: Baseline, 12 months, 24 months, 36 months and 48 months

  5. Percentage of Participants Free From Relapse

    Time frame: Year 2 and Year 4

  6. Time From Onset of Relapse to Recovery

    Time frame: Up to Month 48

  7. Annualized Relapse Rate (ARR)

    Time frame: At Year 2 and Year 4

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

    Time frame: At Year 1, Year 2, Year 3 and Year 4

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

    Time frame: At Year 1, Year 2, Year 3 and Year 4

  10. Timed 25-Foot Walk (T25FW) Score

    Time frame: 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

    Time frame: Baseline, Year 1, Year 2, Year 3 and Year 4

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Year 1, Year 2, Year 3 and Year 4

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

    Time frame: Year 2 and Year 4

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

    Time frame: Year 2 and Year 4

  19. 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

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

    Time frame: 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)

    Time frame: Baseline, Year 1, Year 2, Year 3 and Year 4

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

    Time frame: Up to 48 months

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

    Time frame: Baseline, Year 1, Year 2, Year 3 and Year 4

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Apr 4, 2023
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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