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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavenclad | Drug | This is an observational study, participants who received cladribine tablets in routine clinical practice following the SmPC will be included. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discontinuation of Treatment with Cladribine tablets | Up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCL Saint Luc | Brussels | Belgium | ||||
| UZ Antwerpen |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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|
| 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 |
| Time From Onset of Relapse to Recovery | Up to Month 48 |
| Annualized Relapse Rate (ARR) | At Year 2 and Year 4 |
| 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 |
| Timed 25-Foot Walk (T25FW) Score | 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 | 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 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 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 |
| 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 With Minimal Evidence of Disease Activity (MEDA) | Year 2 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 |
| EuroQol 5-Dimensions (EQ-5D-5L) 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 |
| Treatment Cost of Disease-Modifying Treatment (DMTs) | Up to 48 months |
| EuroQol Visual Analog Scale (EQ-VAS) Score | Baseline, Year 1, Year 2, Year 3 and Year 4 |
| Edegem |
| Belgium |
| AZ Groeninge vzw | Kortrijk | Belgium |
| CHU Sart Tilman | Liège | Belgium |
| FN u sv. Anny Brno | Brno | Czechia |
| FN Hradec Králové | Hradec Králové | Czechia |
| NeuropsychiatrieHK | Hradec Králové | Czechia |
| Fakultni nemocnice Ostrava | Ostrava | Czechia |
| Nemocnice Teplice | Teplice | Czechia |
| University of Thrace, Medical School - Neurology Department, Alexandroupoli | Alexandroupoli | Greece |
| Aiginiteio' Hospital | Athens | Greece |
| Attikon | Athens | Greece |
| Evagelismos | Athens | Greece |
| General Miliary Hospital of Athens "401" | Athens | Greece |
| University of Ioannina - Neurology department | Ioannina | Greece |
| University Hospital of Larissa | Larissa | Greece |
| General Hospital "Agios Andreas" | Pátrai | Greece |
| University of Patras | Pátrai | 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 |
| Centro Hospitalar Lisboa Norte Hospital de Santa Maria | Lisbon | Portugal |
| Centro Hospitalar Universitário Lisboa Central - Hospital dos Capuchos | Lisbon | Portugal |
| Centro Hospitalar de São João E. P. E. | Porto | Portugal |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D017338 | Cladribine |
| ID | Term |
|---|---|
| D015762 | 2-Chloroadenosine |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003839 | Deoxyadenosines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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