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

Active, not recruiting

• Conditions: Multiple Sclerosis
• Interventions: Drug: Mavenclad

• Registration Number: NCT05797740
• Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-04-04
• Study Start: 2023-08-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-09
• Primary Completion: 2029-01-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single cohort	Mavenclad	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).

Primary Outcome Measures

Name	Time	Method
Time to Discontinuation of Treatment with Cladribine tablets	Up to 48 months

Secondary Outcome Measures

Name	Time	Method
Cumulative Cladribine Dose	Up to 48 months
Percentage of Participants Free From Relapse	Year 2 and Year 4
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
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
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
Proportion of Severe Relapses	Baseline, 12 months, 24 months, 36 months and 48 months
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
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
Percentage of Participants With Minimal Evidence of Disease Activity (MEDA)	Year 2 and Year 4
Treatment Cost of Disease-Modifying Treatment (DMTs)	Up to 48 months
Percentage of Participants Free From Magnetic Resonance Imaging (MRI) Activity	At Year 1, Year 2, Year 3 and Year 4
Percentage of Participants with Minimal MRI Activity (=< 2 New T2 Lesions)	At Year 1, Year 2, Year 3 and Year 4
Percentage of Participants With No Evidence of Disease Activity (NEDA-3)	Year 2 and Year 4
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
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
EuroQol Visual Analog Scale (EQ-VAS) Score	Baseline, Year 1, Year 2, Year 3 and Year 4
Number of Relapses	Baseline, 12 months, 24 months, 36 months and 48 months
Time From Onset of Relapse to Recovery	Up to Month 48
Annualized Relapse Rate (ARR)	At Year 2 and Year 4
Timed 25-Foot Walk (T25FW) Score	Baseline, Year 1, Year 2, Year 3 and Year 4
9-Hole Peg Test (9HPT) Score	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	Year 1, Year 2, Year 3 and Year 4
EuroQol 5-Dimensions (EQ-5D-5L) Score	Baseline, Year 1, Year 2, Year 3 and Year 4

Trial Locations

Locations (30)

General Miliary Hospital of Athens "401"; 🇬🇷 Athens, Greece

Centro Hospitalar Lisboa Norte Hospital de Santa Maria; 🇵🇹 Lisboa, Portugal

Centro Hospitalar Universitário Lisboa Central - Hospital dos Capuchos; 🇵🇹 Lisbon, Portugal

Centro Hospitalar de São João E. P. E.; 🇵🇹 Porto, Portugal

Attikon; 🇬🇷 Athens, Greece

UCL Saint Luc; 🇧🇪 Bruxelles, Belgium

UZ Antwerpen; 🇧🇪 Edegem, Belgium

AZ Groeninge vzw; 🇧🇪 Kortrijk, Belgium

CHU Sart Tilman; 🇧🇪 Liege 1, Belgium

Evagelismos; 🇬🇷 Athens, Greece

FN u sv. Anny Brno; 🇨🇿 Brno, Czechia

FN Hradec Králové; 🇨🇿 Hradec Kralove, Czechia

NeuropsychiatrieHK; 🇨🇿 Hradec Kralove, Czechia

Fakultni nemocnice Ostrava; 🇨🇿 Ostrava, Czechia

Nemocnice Teplice; 🇨🇿 Teplice, Czechia

University of Thrace, Medical School - Neurology Department, Alexandroupoli; 🇬🇷 Alexandroupoli, Greece

Aiginiteio' Hospital; 🇬🇷 Athens, Greece

University of Ioannina - Neurology department; 🇬🇷 Ioannina, Greece

University Hospital of Larissa; 🇬🇷 Larissa, Greece

General Hospital "Agios Andreas"; 🇬🇷 Patras, Greece

University of Patras; 🇬🇷 Patras, Greece

AHEPA University Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece

General Hospital of Athens G.Gennimatas; 🇬🇷 Thessaloniki, Greece

Interbalkan Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece

St Luke's Clinic; 🇬🇷 Thessaloniki, Greece

Zuyderland; 🇳🇱 Sittard-Geleen, Netherlands

Oddział Kliniczny Neurologii, Szpital Uniwersytecki w Krakowie; 🇵🇱 Krakow, Poland

Medical Academy Neurology Clinic; 🇵🇱 Poznan, Poland

Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie; 🇵🇱 Szczecin, Poland

Centro Hospitalar e Universitario de Coimbra; 🇵🇹 Coimbra, Portugal