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

NCT05797740 | Active Not Recruiting

• 1 other identifier: MS700568_0213
• Study Type: observational
• Target: 367
• Locations: 6 countries
• Sites: 30

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Relapsing Multiple Sclerosis; Mavenclad; Cladribine Tablets

Outcome Measures

Primary Outcomes (1)

• Time to Discontinuation of Treatment with Cladribine tablets

  Up to 48 months

Secondary Outcomes (23)

• 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

• Cumulative Cladribine Dose

  Up to 48 months

• Number of Relapses

  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 Free From Relapse

  Year 2 and Year 4

Study Arms (1)

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

Interventions

Mavenclad DRUG

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

Also known as: Cladribine

Single cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (30)

UCL Saint Luc

Brussels, Belgium

Location

UZ Antwerpen

Edegem, Belgium

Location

AZ Groeninge vzw

Kortrijk, Belgium

Location

CHU Sart Tilman

Liège, Belgium

Location

FN u sv. Anny Brno

Brno, Czechia

Location

FN Hradec Králové

Hradec Králové, Czechia

Location

NeuropsychiatrieHK

Hradec Králové, Czechia

Location

Fakultni nemocnice Ostrava

Ostrava, Czechia

Location

Nemocnice Teplice

Teplice, Czechia

Location

University of Thrace, Medical School - Neurology Department, Alexandroupoli

Alexandroupoli, Greece

Location

Aiginiteio' Hospital

Athens, Greece

Location

Attikon

Athens, Greece

Location

Evagelismos

Athens, Greece

Location

General Miliary Hospital of Athens "401"

Athens, Greece

Location

University of Ioannina - Neurology department

Ioannina, Greece

Location

University Hospital of Larissa

Larissa, Greece

Location

General Hospital "Agios Andreas"

Pátrai, Greece

Location

University of Patras

Pátrai, Greece

Location

AHEPA University Hospital of Thessaloniki

Thessaloniki, Greece

Location

General Hospital of Athens G.Gennimatas

Thessaloniki, Greece

Location

Interbalkan Hospital of Thessaloniki

Thessaloniki, Greece

Location

St Luke's Clinic

Thessaloniki, Greece

Location

Zuyderland

Sittard-Geleen, Netherlands

Location

Oddział Kliniczny Neurologii, Szpital Uniwersytecki w Krakowie

Krakow, Poland

Location

Medical Academy Neurology Clinic

Poznan, Poland

Location

Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie

Szczecin, Poland

Location

Centro Hospitalar e Universitario de Coimbra

Coimbra, Portugal

Location

Centro Hospitalar Lisboa Norte Hospital de Santa Maria

Lisbon, Portugal

Location

Centro Hospitalar Universitário Lisboa Central - Hospital dos Capuchos

Lisbon, Portugal

Location

Centro Hospitalar de São João E. P. E.

Porto, Portugal

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cladribine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Medical Responsible

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: August 3, 2023
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

BE (4); GR (13); NL (1); PL (3); PT (4); CZ (5)