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NCT00548405 · ClinicalTrials.gov registry record · Phase 3
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 840
- Enrollment target
NCT00548405: Completed Phase 3 study, sponsored by Genzyme, a Sanofi Company.
NCT00548405 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 840 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00548405, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 840 participants
- Enrollment target
Study Summary
The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.
Primary Outcome
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Basel
Interventions
- BIOLOGICAL Interferon beta-1a
- BIOLOGICAL Alemtuzumab 12 mg
- BIOLOGICAL Alemtuzumab 24 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 840 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
What the finished NCT00548405 record still lists
NCT00548405 is an interventional study that assigns participants to a tested intervention. The registered 840 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Interferon beta-1a is the first listed.
NCT00548405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00548405 about?
NCT00548405 is a clinical study titled "Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two". The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequa...
What is the current status of trial NCT00548405?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 840 participants. The study started on 2007-10. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00548405?
The interventions under investigation include: Interferon beta-1a (BIOLOGICAL), Alemtuzumab 12 mg (BIOLOGICAL), Alemtuzumab 24 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT00548405?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00548405's enrollment target sits among peer trials
840 392nd of 2000 higher than 1,607 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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