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

PHASE3CompletedINTERVENTIONAL
Enrollment

840

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
BIOLOGICAL

Alemtuzumab 12 mg

Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.

BIOLOGICAL

Alemtuzumab 24 mg

Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.

BIOLOGICAL

Interferon beta-1a

Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.

Trial Locations (191)

2170

Liverpool Hospital, Neurology Department, Liverpool

3050

Royal Melbourne Hospital, Department of Neurology, Parkville

4066

The Wesley Research Institute, Auchenflower

7000

Royal Hobart Hospital, Hobart

Unknown

North Central Neurology Associates, P.C., Cullman

Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix

Hope Research Institute, Phoenix

Mayo Clinic Arizona, Department of Neurology, Scottsdale

Northwest NeuroSpecialists, PLLC, Tucson

East Bay Physicians Medical Group/Sutter East Bay Medical Foundation, Berkeley

Neurology Center of North Orange County, La Habra

Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles

Neuro-Therapeutics Inc., Pasadena

Neuro-Therapeutics, Inc, Pasadena

University of California, Davis Medical Center, Sacramento

Stanford University School of Medicine, Stanford

University of Colorado Hospital, Anschutz Outpatient Pavilioin, Aurora

Neurological Consultants, Denver

Advanced Neurosciences Research, Fort Collins

Yale University, New Haven

George Washington University Medical Faculty Associates, Washington D.C.

University of Florida Neuroscience Institute, Jacksonville

Neurology Associates, P.A., Maitland

Neurological Associates, Pompano Beach

Negroski, Stein, Sutherland and Hanes Neurology, Sarasota

Axiom Clinical Research of Florida, Tampa

University of South Florida, Department of Neurology, Tampa

Emory University, Department of Neurology, Atlanta

Shepherd Center, Inc., Atlanta

Idaho Falls Multiple Sclerosis Center, PLLC, Idaho Falls

University of Chicago Medical Center, Department of Neurology, Chicago

Consultants in Neurology, Ltd, Northbrook

Fort Wayne Neurological Center, Fort Wayne

Indiana University School of Medicine, Department of Neurology, Indianapolis

Josephson Wallack Munshower Neurology P.C., Indianapolis

Iowa Health Physicians, Des Moines

Ruan Neurology Clinic and Research Center, Des Moines

University of Kansas Medical Center, Department of Neurology, Kansas City

MidAmerica Neuroscience Institute, Lenexa

Associates in Neurology, PSC, Lexington

University of Louisville Research Foundation, Louisville

Louisiana State University Health Sciences Center, Shreveport

Caritas St. Elizabeth's Medical Center, Boston

Partners Multiple Sclerosis Center/Brigham and Women's Hospital, Boston

Springfield Neurology Associates, LLC, Springfield

UMass Memorial Medical Center, Worcester

University of Michigan Department of Neurology, Ann Arbor

Henry Ford Hospital, Detroit

Wayne State University, School of Medicine, Department of Neurology, Detroit

Spectrum Health Medical Group, Neurology (Previously known as Michigan Medical P.C., Neurology), Grand Rapids

Michigan Neurology Associates, P.C., Saint Clair Shores

Northern Michigan Neurology, Traverse City

Mayo Clinic Rochester, Rochester

Neurology Consultants of Kansas City, Inc., Kansas City

Montana Neurobehavioral Specialists, Missoula

University of Nevada School of Medicine, Las Vegas

Renown Institute for Neurosciences / Renown regional Medical Center, Reno

Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center, Lebanon

MS Center at Holy Name Hospital, Teaneck

University of New Mexico, Health Sciences Center, MS Specialty Clinic, Albuquerque

Empire Neurology, PC, Latham

Winthrop University Hospital, Clinical Trials Center, Mineola

Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, New York

Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C., Patchogue

University of Rochester Medical Center, Rochester

SUNY Upstate Medical University, Department of Neurology, Syracuse

University of North Carolina-Chapel Hill, Department of Neurology, Chapel Hill

Wake Forest University Health Science, Department of Neurology, Winston-Salem

Cleveland Clinic Foundation, Mellen Center, Cleveland

Neurology Specialists, Inc., Dayton

Oak Clinic for Multiple Sclerosis, Uniontown

MS Center of Oklahoma, Oklahoma City

Lehigh Valley Hospital, Neuroscience and Pain Research, Allentown

Northshore Clinical Associates, Erie

University of Pittsburgh, Kaufmann Medical Building, Pittsburgh

The Neurology Foundation, Inc., Providence

Neurology Clinic, P.C., Cordova

Advanced Neurosciences Institute, Franklin

Biomedical Research Alliance of NY, LLC, Franklin

Hope Neurology PC, Knoxville

Vanderbilt Multiple Sclerosis Center, Nashville

Clinical Center for Multiple Sclerosis, Dallas

Central Texas Neurology, Round Rock

Integra Clinical Research, San Antonio

Neurology Center of San Antonio, San Antonio

MS Center of Greater Washington, P.C., Vienna

Swedish Neuroscience Institute, Seattle

Virginia Mason Medical Center, Seattle

Rockwood Clinical Research Center, Spokane

DIABAID, Buenos Aires

Westmead Hospital, Westmead

Griffith School of Medicine, Gold Coast Campus, Griffith University, Southport

Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department, Woodville South

St. Vincent's Hospital, MS Education & Research, Department of Clinical Neurosciences, Fitzroy

Austin Health, Heidelberg

Concord Repatriation General Hospital, Neurosciences Department, Concord

Southern Neurology, Kogarah

AKH Wien, Universitätsklinikum für Neurologie, Vienna

Cliniques Universitaires Saint-Luc, Neurology, Brussels

CHU Ourthe Amblève, Neurology, Esneux

University Hospital Leuven, Campus Gasthuisberg, Neurology, Leuven

Hospital da Restauracao, Recife

Hospital Sao Lucas PUC-RS, Porto Alegre

Hospital de Clínicas USP, São Paulo

Irmandade da Santa Casa de Misericordia de Sao Paulo, São Paulo

UBC Hospital, Vancouver

Multiple Sclerosis Clinic, Connell 7, Kingston General Hospital, Kingston

London Health Sciences Centre- University Hospital, London

The Ottawa Hospital, General Campus, Ottawa

Sunnybrook Health Sciences Centre, Toronto

Centre de Sante et de Services Sociaux de Gatineau-Hull Hospital, Gatineau

Clinique Neuro rive-sud, Recherche sepmus inc, Greenfield Park

Hospital Maisonneuve-Rosemont, Montreal

Montreal Neurological Institute and Hospital, Montreal

Clinical Hospital Centre Rijeka, Clinic for Neurology, Rijeka

General Hospital Varazdin, Department of neurology, Varaždin

Clinical Hospital Centre Zagreb, Zagreb

Clinical Hospital Sestre Milosrdnice, Zagreb

"General Hospital Sveti Duh, Department of neurology", Zagreb

MS Center, Department of Neurology, Hradec Králové

St. Anne's University Hospital Brno, Pekarska

Department of Neurology 1st Faculty of Medicine and General Teaching Hospital, MS Center, Prague

Krajska zdravotni a.s. - Hospital Teplice, Teplice

Århus Universitetshospital, Scleroseklinikken, Århus Sygehus, Aarhus

Scleroseklinikken, Rigshospitalet, Copenhagen

Odense University Hospital, Odense

CHU Clermont-Ferrand, Hôpital Gabriel Montpied, Clermont-Ferrand

Hôpital General, Service de Neurologie, Dijon

Hospital Roger Salengro, Lille

Hôpital Pitié Salpétrière, Service de Neurologie, Paris

Sevice de Neurologie, Rennes

Hôpital Civil, Departement de Neurologie, Strasbourg

Krankenhaus Hohe Warte, Betriebsstätte der Bayreuth, Bayreuth

Judisches Krankenhaus Berlin, Berlin

Neurologisches Fachzentrum Berlin, Berlin

Neurologische Universitätsklinik Bonn, Bonn

Multiple Sklerose Zentrum am, Zentrum für klinische Neurowissenschaften, Neurologische Uniklinik Dresden, Dresden

Asklepios Klinic Barmbek, Hamburg

Medizinische Hochshule Hannover, Hanover

Oberhavelkliniken Hennigsdorf, Hennigsdorf

Klinikum Ingolstadt, Neurologische Klinik, Ingolstadt

Klinikum Rechts der Isar, Klinik für Neurologie, München

Klinik und Poliklinik fur Neurologie der Universitat Rockstock, Rostock

Universitatsklinik Ulm, Ulm

Fachkrankenhaus Hubertusburg, Wermsdorf

Hadassah Medical Center Ein Karem, Jerusalem

Tel Aviv Sourasky Medical Center, Department of Neurology, Tel Aviv

Sheba Medical Centre, Tel Litwinsky

Ospedale Binaghi - Centro Sclerosi Multipla, Cagliari

Ospedale S. Antonio Abate di Gallarate, Gallarate

Università di Genova Dipartimento di Neuroscienze Oftalmologia e Genetica, Genova

Ospedale Civile di Brescia c/o Ospedale Richiedei, Centro di riferimento per la Sclerosi Multiple, Montichiari

Ospedale San Luigi di Orbassano, Orbassano

Azienda Ospedaliera Sant'Andrea Neurologia, Roma

Unidad de Investigación en Salud de Chihuahua, S.C., Chihuahua City

Hospital Medica Sur CIF-BIOTEC, Delegacion

Hospital Angeles del Pedregal; Camino a Santa Teresa, Mexico City

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch

Orbis Medisch Centrum, Department of Neurology, Sittard

Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz, Lodz

Independent Public Teaching Hospital No. 4 in Lublin, Lublin

Heliodor Swiecicki Teaching Hospital of the Poznan, University of Medical Sciences, Poznan

"Research Medical Complex Your Health Ltd", Kazan'

"Institution of the Russian Academy of Medical Sciences, Neurology Scientific Center under RAMS", Moscow

Moscow State Medical Institution City Clinical Hospital #11, Moscow City Center for Multiple Sclerosis, Moscow

Moscow State Public Medical Institution, City Clinical Hospital #11, Moscow

"Municipal Treatment and Prevention Institution, City Hospital #33", Nizhny Novgorod

Federal State Institution: Siberian District Medical Center, Novosibirsk

"Institution of the Russian Academy of Sciences, Institute of the Human Brain n.a. N.P. Bekhtereva within the Russian Academy of Sciences", Saint Petersburg

St. Petersburg Pavlov State Medical University, Department of Neurology and Neurosurgery with a Clinic, Saint Petersburg

"St.Petersburg State Medical Institution, City Multispecialty Hospital #2", Saint Petersburg

"St.Petersburg State Medical Institution, Nikolayevskaya Hospital", Saint Petersburg

"State Medical Institution, Samara Regional Clinical Hospital n.a. M.I. Kalinin", Samara

Clinic of Neurology, Clinical Centre of Serbia, Belgrade

Military Medical Academy, Belgrade

Clinical Centre of Kragujevac, Kragujevac

Clinical Centre Vojvodina Institute of Neurology, Novi Sad

Servicio de Neurología Hospital Vall d'Hebron Paseo de Vall d'Hebron, Barcelona

Servicio de Neurología Hospital Clínico San Carlos, Madrid

Servicio de Neurología Hospital Carlos Haya, Málaga

Servicio de Neurología Hospital Virgen de la Macarena, Seville

Sahlgrenska University Hospital, Neurologkliniken, Gothenburg

Norrlands Universitets sjukhus, Umeå

Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine, Kharkiv

Kyiv Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System, Kyiv

Danylo Halytsky Lviv National Medical University, Department of Neurology, Lviv

Department Of Neurosciences, Addenbrookes Hospital, Cambridge

Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science Barts and The London School of Medicine and Dentistry, London

Frenchay Hospital, Bristol

Salford Royal NHS Foundation Trust, Clinical Trials Unit, Salford

Department of Neurology Glossop Road, Royal Hallamshire Hospital, Sheffield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Genzyme, a Sanofi Company

INDUSTRY