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NCT00078338 · ClinicalTrials.gov registry record · Phase 4
Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
A Phase 4 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 4
- Development phase
- 764
- Enrollment target
NCT00078338: Completed Phase 4 study, sponsored by EMD Serono.
NCT00078338 is a Phase 4 study that has completed, run by EMD Serono. The registered enrollment target is 764 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00078338, a Phase 4 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 764 participants
- Enrollment target
Study Summary
The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.
Primary Outcome
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by subject and must be accompanied by at least 1 of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Di
Interventions
- DRUG Rebif®
- DRUG Copaxone®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 764 participants |
| Start Date | 2004-02-16 |
| Est. Completion | 2006-11-28 |
| Phase | Phase 4 |
What the finished NCT00078338 record still lists
NCT00078338 is an interventional study that assigns participants to a tested intervention. The registered 764 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which Rebif® is the first listed.
NCT00078338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00078338 about?
NCT00078338 is a clinical study titled "Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis". The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.
What is the current status of trial NCT00078338?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 764 participants. The study started on 2004-02-16. Estimated completion is 2006-11-28.
What interventions are being tested in trial NCT00078338?
The interventions under investigation include: Rebif® (DRUG), Copaxone® (DRUG).
Who is sponsoring clinical trial NCT00078338?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00078338's enrollment target sits among peer trials
764 106th of 2000 higher than 1,895 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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