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Effects of CLADribine tablets on the Immune Synapse, in Relapsing Multiple Sclerosis (RMS) patients_CLADIS.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521910-24-00
Enrollment
30
Registered
2026-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

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

Detailed description

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, Change in EDSS at the end of year 1, compared to baseline, Change in T25FW at the end of year 1, compared to baseline, Change in 9HPT at the end of year 1, compared to baseline, Number of T1 lesions (Gd+ and black holes) at the end of year 1, compared to baseline, Number of T2 lesions (total, new/enlarging) at the end of year 1, compared to baseline, Number 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, 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, 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

Interventions

Sponsors

Aristotle University Of Thessaloniki
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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, Change in EDSS at the end of year 1, compared to baseline, Change in T25FW at the end of year 1, compared to baseline, Change in 9HPT at the end of year 1, compared to baseline, Number of T1 lesions (Gd+ and black holes) at the end of year 1, compared to baseline, Number of T2 lesions (total, new/enlarging) at the end of year 1, compared to baseline, Number 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, 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, Correlation of changes

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 18, 2026