BENITIONSClinical Trial Intelligence

Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis

Phase 4 Completed NCT03963375

ConditionMultiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
PhasePhase 4
SponsorGregory Wu
StatusCompleted
Enrollment47 participants
InterventionsCladribine
Start dateOct 28, 2019
Completion dateMay 27, 2025
Results postedJul 28, 2026

Summary

The purpose of this study is to better understand the mechanism of action (MoA) of cladribine tablets by exploring the effect on central nervous system (CNS) and blood biomarkers relevant in the relapsing forms of multiple sclerosis (RMS; to include relapsing-remitting MS \[RRMS\] or active secondary progressive MS).

Change in CD3+ T Cells % From Baseline to Week 5

Baseline to Week 5 (5 weeks after first cladribine dose) · Percentage of CD3+ T cells

Week 50.7 Percentage of CD3+ T cells
p-value0.72

Change in CD3+ T Cells % From Baseline to Week 10

Baseline to Week 10 (10 weeks after first cladribine dose) · Percentage of CD3+ T cells

Week 10-2.3 Percentage of CD3+ T cells
p-value0.08

Change in CD3+ T Cells % From Baseline to Year 1

Baseline to Year 1 (45 weeks after first cladribine dose) · Percentage of CD3+ T cells

Year 1-7.6 Percentage of CD3+ T cells
p-value0.04

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