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NCT04877457 · ClinicalTrials.gov registry record · Phase 4
Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.
A Phase 4 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT04877457: Clinical Trial Phase 4 study, sponsored by Yale University.
NCT04877457 is a Phase 4 study that was terminated before completion, run by Yale University. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04877457, a Phase 4 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 4 study in which eligible patients with RADIOLOGICALLY ISOLATED SYNDROME (RIS) (as defined by meeting 2017 McDonald criteria for DIS) will be randomized 1:1 to receive ocrelizumab treatment or placebo (standard of care).
Primary Outcome
The primary efficacy endpoint for this study is to evaluate the efficacy of ocrelizumab compared with placebo on delaying the time to development of new radiological or clinical evidence of MS, defined as the time from baseline to first new T1 gadolinium-enhancing lesions and/or new or enlarging T2 lesions consistent with MS in participants OR first clinical evidence of MS, i.e., neurological event resulting from CNS demyelination as evidenced by acute or progressive clinical syndrome consistent
Interventions
- OTHER Placebo
- DRUG Ocrelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-02-15 |
| Est. Completion | 2023-06-12 |
| Phase | Phase 4 |
Why NCT04877457 stopped before completion
NCT04877457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04877457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04877457 about?
NCT04877457 is a clinical study titled "Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.". This is a multicenter, randomized, double-blind, placebo-controlled, Phase 4 study in which eligible patients with RADIOLOGICALLY ISOLATED SYNDROME (RIS) (as defined by meeting 2017 McDonald criteria for DIS) will be randomized 1:1 to receive ocrelizumab treatment or placebo (standard of care).
What is the current status of trial NCT04877457?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2022-02-15. Estimated completion is 2023-06-12.
What interventions are being tested in trial NCT04877457?
The interventions under investigation include: Placebo (OTHER), Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT04877457?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04877457's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 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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