A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

PHASE2CompletedINTERVENTIONAL
Enrollment

334

Participants

Timeline

Start Date

December 31, 2002

Primary Completion Date

September 30, 2007

Study Completion Date

January 31, 2010

Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
BIOLOGICAL

Interferon beta-1a

Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 36 months.

BIOLOGICAL

Alemtuzumab 12 mg

Alemtuzumab 12 milligram per day (mg/day) was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the cluster of differentiation 4+ \[CD4+\] T-cell count was \>=100\*10\^6 cells per liter).

BIOLOGICAL

Alemtuzumab 24 mg

Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was \>=100\*10\^6 cells per liter).

Trial Locations (49)

11794

University Hospital an Medical Center, Stony Brook

21201

University of Maryland -Maryland Center for MS, Baltimore

27103

ALL-Trials Clinical Research, LLC, Winston-Salem

31909

Medical Research and Health Education, Columbus

32806

Neurological Service of Orlando, Orlando

33060

Neurological Associates/ Research Dept., Pompano Beach

33609

Axiom Clinical Research of Florida, Tampa

37934

Neurology, PC, Knoxville

40503

Associate in Neurology, Lexington

46805

Fort Wayne Neurological Center, Fort Wayne

48201

Wayne State University Department of Neurology, Detroit

48334

Michigan Institute for Neurological Disorders, Farmington Hills

49525

Michigan Medical P.C. Neurology, Grand Rapids

55905

Mayo Clinic Rochester Department of Neurology, Rochester

60062

Consultants in Neurology, Ltd, Northbrook

72205

Clinical Trials, Inc, Little Rock

74137

Neurological Associates of Tulsa, Inc, Tulsa

75080

Dallas Neurological Associate, Richardson

78231

Integra Clinical Research, LLC, San Antonio

78258

Neurology Center of San Antonio, San Antonio

78681

Central Texas Neurology Consultants PA, Round Rock

80218

Neurologic Research Institute/Mile High Research Center, Denver

85259

Mayo Clinic Scottsdale Arizona, Scottsdale

89102

Nevada Neurological Consultants, Ltd., Las Vegas

91105

Neuro-Therapeutics, Inc., Pasadena

92618

Nerve Pro Research, Irvine

94705

East Bay Physicians Medical Group, Berkeley

117437

Russian State Medical University, Moscow

125367

Neurology Scientific Center RAMS, Moscow

197376

Institute of Human brain RAS, Saint Petersburg

938-1343

Neurological Research Institute of the East Bay, Walnut Creek

3335-6637

Neurology Clinical Research, Inc., Sunrise

18103-6296

Neurosciencies and Pain Research, Allentown

Unknown

Baylor College of Medicine, Houston

"Department of Neurology, University Hospital Osijek", Osijek

"Department of Neurology, Clinical Hospital Centre Rijeka", Rijeka

"Department of Neurology, Clinical Hospital Centre Zagreb", Zagreb

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

"Department of Neurology, University Hopsital Sestre Milosrdnice", Zagreb

Centrum Neurologii Klinicznej, Krakow

Samodzielny Publiczny Zakład Opieki Zdrowotnej, Lodz

Klinika Neurologii, Lublin

Oddzial Kliniczny Neurologii, Poznan

Instytut Psychiatrii i Neurologii, Warsaw

Katedra i Klinika Neurologii, Warsaw

Moscow City Hospital #11, Moscow

Moscow City Hospital #61, Moscow

St. Petersburg State Pavlov Medical University, Saint Petersburg

Addenbrooke's Hospital, Cambridge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Genzyme, a Sanofi Company

INDUSTRY