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Completed Phase 3 Interventional Results available

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two

ClinicalTrials.gov ID: NCT00548405

Public ClinicalTrials.gov record NCT00548405. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 2:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00548405
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Genzyme, a Sanofi Company
Industry
Enrollment
840 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2007 (Type not available)
Primary completion
Sep 2011 (Actual)
Completion
Sep 2011 (Actual)
Last update posted
Apr 17, 2017

2007 – 2011

United States locations

U.S. sites
85
U.S. states
34
U.S. cities
74
Facility City State ZIP Site status
North Central Neurology Associates, P.C. Cullman Alabama — —
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center Phoenix Arizona — —
Hope Research Institute Phoenix Arizona — —
Mayo Clinic Arizona, Department of Neurology Scottsdale Arizona — —
Northwest NeuroSpecialists, PLLC Tucson Arizona — —
East Bay Physicians Medical Group/Sutter East Bay Medical Foundation Berkeley California — —
Neurology Center of North Orange County La Habra California — —
Department of Neurology, Keck School of Medicine, University of Southern California Los Angeles California — —
Neuro-Therapeutics Inc. Pasadena California — —
Neuro-Therapeutics, Inc Pasadena California — —
University of California, Davis Medical Center Sacramento California — —
Stanford University School of Medicine Stanford California — —
University of Colorado Hospital, Anschutz Outpatient Pavilioin Aurora Colorado — —
Neurological Consultants Denver Colorado — —
Advanced Neurosciences Research Fort Collins Colorado — —
Yale University New Haven Connecticut — —
George Washington University Medical Faculty Associates Washington D.C. District of Columbia — —
University of Florida Neuroscience Institute Jacksonville Florida — —
Neurology Associates, P.A. Maitland Florida — —
Neurological Associates Pompano Beach Florida — —
Negroski, Stein, Sutherland and Hanes Neurology Sarasota Florida — —
Axiom Clinical Research of Florida Tampa Florida — —
University of South Florida, Department of Neurology Tampa Florida — —
Emory University, Department of Neurology Atlanta Georgia — —
Shepherd Center, Inc. Atlanta Georgia — —
Idaho Falls Multiple Sclerosis Center, PLLC Idaho Falls Idaho — —
University of Chicago Medical Center, Department of Neurology Chicago Illinois — —
Consultants in Neurology, Ltd Northbrook Illinois — —
Fort Wayne Neurological Center Fort Wayne Indiana — —
Indiana University School of Medicine, Department of Neurology Indianapolis Indiana — —
Josephson Wallack Munshower Neurology P.C. Indianapolis Indiana — —
Iowa Health Physicians Des Moines Iowa — —
Ruan Neurology Clinic and Research Center Des Moines Iowa — —
University of Kansas Medical Center, Department of Neurology Kansas City Kansas — —
MidAmerica Neuroscience Institute Lenexa Kansas — —
Associates in Neurology, PSC Lexington Kentucky — —
University of Louisville Research Foundation Louisville Kentucky — —
Louisiana State University Health Sciences Center Shreveport Louisiana — —
Caritas St. Elizabeth's Medical Center Boston Massachusetts — —
Partners Multiple Sclerosis Center/Brigham and Women's Hospital Boston Massachusetts — —
Springfield Neurology Associates, LLC Springfield Massachusetts — —
UMass Memorial Medical Center Worcester Massachusetts — —
University of Michigan Department of Neurology Ann Arbor Michigan — —
Henry Ford Hospital Detroit Michigan — —
Wayne State University, School of Medicine, Department of Neurology Detroit Michigan — —
Spectrum Health Medical Group, Neurology (Previously known as Michigan Medical P.C., Neurology) Grand Rapids Michigan — —
Michigan Neurology Associates, P.C. Saint Clair Shores Michigan — —
Northern Michigan Neurology Traverse City Michigan — —
Mayo Clinic Rochester Rochester Minnesota — —
Neurology Consultants of Kansas City, Inc. Kansas City Missouri — —
Montana Neurobehavioral Specialists Missoula Montana — —
University of Nevada School of Medicine Las Vegas Nevada — —
Renown Institute for Neurosciences / Renown regional Medical Center Reno Nevada — —
Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center Lebanon New Hampshire — —
MS Center at Holy Name Hospital Teaneck New Jersey — —
University of New Mexico, Health Sciences Center, MS Specialty Clinic Albuquerque New Mexico — —
Empire Neurology, PC Latham New York — —
Winthrop University Hospital, Clinical Trials Center Mineola New York — —
Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis New York New York — —
Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C. Patchogue New York — —
University of Rochester Medical Center Rochester New York — —
SUNY Upstate Medical University, Department of Neurology Syracuse New York — —
University of North Carolina-Chapel Hill, Department of Neurology Chapel Hill North Carolina — —
Wake Forest University Health Science, Department of Neurology Winston-Salem North Carolina — —
Cleveland Clinic Foundation, Mellen Center Cleveland Ohio — —
Neurology Specialists, Inc. Dayton Ohio — —
Oak Clinic for Multiple Sclerosis Uniontown Ohio — —
MS Center of Oklahoma Oklahoma City Oklahoma — —
Lehigh Valley Hospital, Neuroscience and Pain Research Allentown Pennsylvania — —
Northshore Clinical Associates Erie Pennsylvania — —
University of Pittsburgh, Kaufmann Medical Building Pittsburgh Pennsylvania — —
The Neurology Foundation, Inc. Providence Rhode Island — —
Neurology Clinic, P.C. Cordova Tennessee — —
Advanced Neurosciences Institute Franklin Tennessee — —
Biomedical Research Alliance of NY, LLC Franklin Tennessee — —
Hope Neurology PC Knoxville Tennessee — —
Vanderbilt Multiple Sclerosis Center Nashville Tennessee — —
Clinical Center for Multiple Sclerosis Dallas Texas — —
Central Texas Neurology Round Rock Texas — —
Integra Clinical Research San Antonio Texas — —
Neurology Center of San Antonio San Antonio Texas — —
MS Center of Greater Washington, P.C. Vienna Virginia — —
Swedish Neuroscience Institute Seattle Washington — —
Virginia Mason Medical Center Seattle Washington — —
Rockwood Clinical Research Center Spokane Washington — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 106 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00548405, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 17, 2017 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00548405 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →