MS700568_0198
What it found
No result yet.
What was tested
Treatment tested
- Cladribine
DNA inhibitor
What it measured
Main measures
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
Other measures (12)
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
Change in the ARR at year 1, relative to the 12-month pre-treatment period
RelapsesChange in EDSS at the end of year 1, compared to baseline
Disability progressionChange in T25FW at the end of year 1, compared to baseline
Disability progressionChange in 9HPT at the end of year 1, compared to baseline
Disability progressionNumber of T1 lesions (Gd+ and black holes) at the end of year 1, compared to baseline
MRI lesionsNumber of T2 lesions (total, new/enlarging) at the end of year 1, compared to baseline
MRI lesionsNumber CUA at the end of year 1, compared to baseline
Proportion of patients with NEDA-3 at the end of year 1
Proportion of patients with MEDA-3 at the end of year 1
Who could take part
Relapsing MS · 18 to 64
Inclusion: - Patients with RRMS, age ≥18 and ≤50 years old - Treatment naive - Cladribine prescription per the decision of the treating physician and according to the approved MAVENCLAD SmPC in Greece - Absence of other neurological disease - Willingness / ability to provide written informed consent - Full diagnostic workup for MS in the previous 6 months prior to the inclusion to the study Exclusion: - Contraindications to use of cladribine tablets according to the Summary of Product Characteristics - Patients with history of alcohol or drug abuse that could potentially interfere with their participation in the study - Concurrent participation in an investigational study in which patient assessment and/or treatment may be dictated by a protocol - Age <18 or >50 - Evidence of progressive MS - Prior or current use of other DMT - MS diagnosis >6 months prior to the inclusion to the study
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
The primary endpoint is to assess changes in the immune synapse molecules in naive MS patients treated with cladribine tablets compared to healthy volunteers, at 12-months of treatment.
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History
Started
Feb 2026
Finished
Feb 2028
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