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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.

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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

FieldValue
Enrollment Target 840 participants
Start Date 2007-10
Est. Completion 2011-09
Phase Phase 3

Sponsor

Genzyme, a Sanofi Company

196 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.