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

Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05797740
Collaborator
(none)
360
Enrollment
30
Locations
62.6
Anticipated Duration (Months)
12
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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 sclerosis (RMS) in the long term, in a real-world setting.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
360 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)
Anticipated Study Start Date :
May 26, 2023
Anticipated Primary Completion Date :
Aug 11, 2028
Anticipated Study Completion Date :
Aug 11, 2028

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to Discontinuation of Treatment with Cladribine tablets [Up to 48 months]

    Secondary Outcome Measures

    1. Percentage of participants Receiving Each of The Possible Number of Annual Treatment Courses with Cladribine Tablets [Baseline, 12 months, 24 months, 36 months and 48 months]

    2. Cumulative Cladribine Dose [Up to 48 months]

    3. Number of Relapses [Baseline, 12 months, 24 months, 36 months and 48 months]

    4. Proportion of Severe Relapses [Baseline, 12 months, 24 months, 36 months and 48 months]

    5. Percentage of Participants Free From Relapse [Year 2 and Year 4]

    6. Time From Onset of Relapse to Recovery [Up to Month 48]

    7. Annualized Relapse Rate (ARR) [At Year 2 and Year 4]

    8. Percentage of Participants Free From Magnetic Resonance Imaging (MRI) Activity [At Year 1, Year 2, Year 3 and Year 4]

    9. Percentage of Participants with Minimal MRI Activity (=< 2 New T2 Lesions) [At Year 1, Year 2, Year 3 and Year 4]

    10. Timed 25-Foot Walk (T25FW) Score [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 [Baseline, Year 1, Year 2, Year 3 and Year 4]

    12. 9-Hole Peg Test (9HPT) Score [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 [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 [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 [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 [Year 1, Year 2, Year 3 and Year 4]

    17. Percentage of Participants With Minimal Evidence of Disease Activity (MEDA) [Year 2 and Year 4]

    18. Percentage of Participants With No Evidence of Disease Activity (NEDA-3) [Year 2 and Year 4]

    19. Multiple Sclerosis Impact Scale (MSIS-29) Physical Domain Score, Psychological Domain Score and Total Score [Baseline, Year 1, Year 2, Year 3 and Year 4]

    20. EuroQol 5-Dimensions (EQ-5D-5L) Score [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) [Baseline, Year 1, Year 2, Year 3 and Year 4]

    22. Treatment Cost of Disease-Modifying Treatment (DMTs) [Up to 48 months]

    23. EuroQol Visual Analog Scale (EQ-VAS) Score [Baseline, Year 1, Year 2, Year 3 and Year 4]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCL Saint Luc Bruxelles Belgium
    2 UZ Antwerpen Edegem Belgium
    3 AZ Groeninge vzw Kortrijk Belgium
    4 CHU Sart Tilman Liege 1 Belgium
    5 FN u sv. Anny Brno Brno Czechia
    6 FN Hradec Králové Hradec Kralove Czechia
    7 Fakultni nemocnice Ostrava Ostrava Czechia
    8 Nemocnice Teplice Teplice Czechia
    9 University of Thrace, Medical School - Neurology Department, Alexandroupoli Alexandroupoli Greece
    10 251 General Air Force Hospital Athens Greece
    11 Aiginiteio' Hospital Athens Greece
    12 Attikon Athens Greece
    13 General Miliary Hospital of Athens "401" Athens Greece
    14 General Oncology Hospital "Agioi Anargyroi" Athens Greece
    15 University Hospital of Larissa Larissa Greece
    16 General Hospital "Agios Andreas" Patras Greece
    17 University of Patras Patras Greece
    18 AHEPA University Hospital of Thessaloniki Thessaloniki Greece
    19 General Hospital of Athens G.Gennimatas Thessaloniki Greece
    20 Interbalkan Hospital of Thessaloniki Thessaloniki Greece
    21 Papageorgiou General Hospital Thessaloniki Thessaloniki Greece
    22 St Luke's Clinic Thessaloniki Greece
    23 Zuyderland Sittard-Geleen Netherlands
    24 Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok Poland
    25 Medical Academy Neurology Clinic Poznan Poland
    26 Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie Szczecin Poland
    27 Centro Hospitalar e Universitario de Coimbra Coimbra Portugal
    28 Centro Hospitalar Lisboa Norte Hospital de Santa Maria Lisboa Portugal
    29 Centro Hospitalar Universitário Lisboa Central - Hospital dos Capuchos Lisbon Portugal
    30 Centro Hospitalar de São João E. P. E. Porto Portugal

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    ClinicalTrials.gov Identifier:
    NCT05797740
    Other Study ID Numbers:
    • MS700568_0213
    First Posted:
    Apr 4, 2023
    Last Update Posted:
    Apr 4, 2023
    Last Verified:
    Mar 1, 2023
    Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    Multiple Sclerosis
    Relapsing Multiple Sclerosis
    Mavenclad
    Cladribine Tablets
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Cladribine

    Study Results

    No Results Posted as of Apr 4, 2023