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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 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 840 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00548405
The ClinicalTrials.gov registry entry for NCT00548405 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 840 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Interferon beta-1a is the first listed.
NCT00548405 reports 0 study locations.
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.
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