Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis
Phase 4
Completed
NCT03963375
| Condition | Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting |
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| Phase | Phase 4 |
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| Sponsor | Gregory Wu |
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| Status | Completed |
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| Enrollment | 47 participants |
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| Interventions | Cladribine |
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| Start date | Oct 28, 2019 |
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| Completion date | May 27, 2025 |
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| Results posted | Jul 28, 2026 |
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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 5 | 0.7 Percentage of CD3+ T cells |
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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 |
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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 |
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Open in BENITIONS
View on ClinicalTrials.gov
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