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NCT00530348 · ClinicalTrials.gov registry record · Phase 3
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 581
- Enrollment target
NCT00530348: Completed Phase 3 study, sponsored by Genzyme, a Sanofi Company.
NCT00530348 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 581 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00530348, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 581 participants
- Enrollment target
Study Summary
The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.
Primary Outcome
EDSS is an ordinal scale in half-point increments that quantifies 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 Base
Interventions
- BIOLOGICAL Alemtuzumab
- BIOLOGICAL Interferon beta-1a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 581 participants |
| Start Date | 2007-08 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT00530348 record still lists
NCT00530348 is an interventional study that assigns participants to a tested intervention. The registered 581 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Alemtuzumab is the first listed.
NCT00530348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00530348 about?
NCT00530348 is a clinical study titled "Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One". The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disea...
What is the current status of trial NCT00530348?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 581 participants. The study started on 2007-08. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00530348?
The interventions under investigation include: Alemtuzumab (BIOLOGICAL), Interferon beta-1a (BIOLOGICAL).
Who is sponsoring clinical trial NCT00530348?
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 NCT00530348's enrollment target sits among peer trials
581 656th of 2000 higher than 1,345 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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