CLADRIBINE for Relapsing multiple sclerosis | Multiple Sclerosis

Inclusion criteria

• {"criterion_text":"- Patients with RRMS, age ≥18 and ≤50 years old\n- Treatment naive\n- Cladribine prescription per the decision of the treating physician and according to the approved MAVENCLAD SmPC in Greece\n- Absence of other neurological disease\n- Willingness / ability to provide written informed consent\n- Full diagnostic workup for MS in the previous 6 months prior to the inclusion to the study"}

Exclusion criteria

• {"criterion_text":"- Contraindications to use of cladribine tablets according to the Summary of Product Characteristics\n- Patients with history of alcohol or drug abuse that could potentially interfere with their participation in the study\n- Concurrent participation in an investigational study in which patient assessment and/or treatment may be dictated by a protocol\n- Age <18 or >50\n- Evidence of progressive MS\n- Prior or current use of other DMT\n- MS diagnosis >6 months prior to the inclusion to the study"}

Primary endpoints

• {"endpoint_text":"- Change in the expression of the co-stimulatory and adhesion molecules comprising the immune synapse in the relevant subpopulations of the adaptive and innate immune system, at 12- months of treatment, relative to baseline","definition_or_measurement_approach":"Change in expression of co-stimulatory and adhesion molecules comprising the immune synapse measured in relevant adaptive and innate immune cell subpopulations at 12 months of treatment, relative to baseline."}

Secondary endpoints

• {"endpoint_text":"- Change in the expression of the co-stimulatory and adhesion molecules comprising the immune synapse in the relevant subpopulations of the adaptive and innate immune system, at 6- months of treatment, relative to baseline","definition_or_measurement_approach":"Change in expression measured in relevant immune cell subpopulations at 6 months relative to baseline."}
• {"endpoint_text":"- Change in the ARR at year 1, relative to the 12-month pre-treatment period","definition_or_measurement_approach":"Change in annualised relapse rate at year 1 compared to the 12-month pre-treatment period."}
• {"endpoint_text":"- Change in EDSS at the end of year 1, compared to baseline","definition_or_measurement_approach":"Change in Expanded Disability Status Scale score at end of year 1 versus baseline."}
• {"endpoint_text":"- Change in T25FW at the end of year 1, compared to baseline","definition_or_measurement_approach":"Change in Timed 25-Foot Walk at end of year 1 versus baseline."}
• {"endpoint_text":"- Change in 9HPT at the end of year 1, compared to baseline","definition_or_measurement_approach":"Change in 9-Hole Peg Test at end of year 1 versus baseline."}
• {"endpoint_text":"- Number of T1 lesions (Gd+ and black holes) at the end of year 1, compared to baseline","definition_or_measurement_approach":"Count of T1 lesions (gadolinium-enhancing and 'black holes') at end of year 1 versus baseline on MRI."}
• {"endpoint_text":"- Number of T2 lesions (total, new/enlarging) at the end of year 1, compared to baseline","definition_or_measurement_approach":"Count of T2 lesions (total and new/enlarging) at end of year 1 versus baseline on MRI."}
• {"endpoint_text":"- Number CUA at the end of year 1, compared to baseline","definition_or_measurement_approach":"Number of clinical units of activity (CUA) at end of year 1 versus baseline (as specified in protocol)."}
• {"endpoint_text":"- Proportion of patients with NEDA-3 at the end of year 1","definition_or_measurement_approach":"Proportion of patients meeting NEDA-3 criteria at end of year 1."}
• {"endpoint_text":"- Proportion of patients with MEDA-3 at the end of year 1","definition_or_measurement_approach":"Proportion of patients meeting MEDA-3 criteria at end of year 1."}
• {"endpoint_text":"- Correlation of changes in the expression of Immune Synapse molecules in the immune cell populations of interest, with clinical outcomes at the end of year 1","definition_or_measurement_approach":"Correlation analysis between changes in immune synapse molecule expression in specified immune cell populations and clinical outcomes at end of year 1."}
• {"endpoint_text":"- Correlation of changes in the expression of Immune Synapse molecules in the immune cell populations of interest, with MRI outcomes at the end of year 1","definition_or_measurement_approach":"Correlation analysis between changes in immune synapse molecule expression in specified immune cell populations and MRI outcomes at end of year 1."}

Greece

Earliest CTIS Part Ii Submission Date

04-02-2026

Latest Decision Or Authorization Date

17-04-2026

Processing Time Days

72

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Aristotle University Of Thessaloniki

Organisation Type

Educational Institution

Country Of Registered Address

Greece

Third parties

• {"country":"Greece","full_name":"Analysi Iatriki A.E.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}