Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis
Фаза 4
Завершено
NCT03963375
| Заболевание | Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting |
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| Фаза | Фаза 4 |
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| Спонсор | Gregory Wu |
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| Статус | Завершено |
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| Участники | 47 участн. |
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| Вмешательство | Cladribine |
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| Дата начала | 28.10.2019 |
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| Дата завершения | 27.05.2025 |
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| Публикация результатов | 28.07.2026 |
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Кратко
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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