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NCT03963375 · ClinicalTrials.gov registry record · Phase 4
Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis
A Phase 4 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 47
- Enrollment target
NCT03963375: Completed Phase 4 study, sponsored by Washington University School of Medicine.
NCT03963375 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 47 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03963375, a Phase 4 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 47 participants
- Enrollment target
Study 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).
Primary Outcome
Change in CSF level of CD3+ T lymphocytes from Baseline to second LP at Week 5, using quality-controlled flow cytometry and assays. Within-group differences from baseline to Week 5 were analyzed using the Wilcoxon signed-rank test because outcome differences were non-normally distributed. Positive number indicates increase in CD3+ T cell percentage and a negative number indicates decrease in CD3+ T cell percentage.
Interventions
- DRUG Cladribine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2019-10-28 |
| Est. Completion | 2025-05-27 |
| Phase | Phase 4 |
What the finished NCT03963375 record still lists
NCT03963375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Cladribine is the first listed.
NCT03963375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03963375 about?
NCT03963375 is a clinical study titled "Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis". 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 secondar...
What is the current status of trial NCT03963375?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 47 participants. The study started on 2019-10-28. Estimated completion is 2025-05-27.
What interventions are being tested in trial NCT03963375?
The interventions under investigation include: Cladribine (DRUG).
Who is sponsoring clinical trial NCT03963375?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03963375's enrollment target sits among peer trials
47 1348th of 2000 higher than 653 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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