Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two (CARE-MS II)

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: October 22, 2007
Last updated: January 6, 2015
Last verified: January 2015

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.

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Biological: Alemtuzumab 12 mg
Biological: Alemtuzumab 24 mg
Biological: Interferon beta-1a
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Accumulation of Disability (SAD) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.

  • Annualized Relapse Rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.

Secondary Outcome Measures:
  • Percentage of Participants Who Were Relapse Free at Year 2 [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
    Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.

  • Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2 [ Time Frame: Baseline, Year 2 ] [ Designated as safety issue: No ]
    EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.

  • Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2 [ Time Frame: Baseline, Year 2 ] [ Designated as safety issue: No ]
    MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.

  • Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2 [ Time Frame: Baseline, Year 2 ] [ Designated as safety issue: No ]
    Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)*100/ (lesion volume at Baseline).

Enrollment: 840
Study Start Date: October 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alemtuzumab 12 mg 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.
Other Name: Lemtrada
Experimental: Alemtuzumab 24 mg 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.
Other Name: Lemtrada
Active Comparator: Interferon Beta-1a 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.
Other Name: Rebif®

Detailed Description:

Every participant received active treatment; there was no placebo. After Amendment 2, the 24 mg alemtuzumab dose was closed to enrollment so newly enrolled participants were randomly assigned to treatment with either 12 mg alemtuzumab or interferon beta-1a in a 2:1 ratio (that is, 2 given 12 mg alemtuzumab for every 1 given interferon beta-1a). Alemtuzumab was administered in two annual courses, once at the beginning of the study and again 1 year later. Interferon beta-1a was self-injected 3 times per week for 2 years. All participants were required to return to their study site every 3 months for neurologic assessment. In addition, safety-related laboratory tests were performed at least monthly. Participation in this study ended 2 years after the start of treatment for each participant. Additionally, participants who received alemtuzumab might be followed in the CAMMS03409 Extension Study (NCT00930553) for safety and efficacy assessments. Participants who received interferon beta-1a and completed 2 years on study might be eligible to receive alemtuzumab in the Extension Study.


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent form (ICF)
  • Age 18 to 55 years (inclusive) as of the date the ICF was signed
  • Diagnosis of MS per update of McDonald criteria
  • Onset of MS symptoms (as determined by a neurologist; could be retrospectively) within 10 years of the date the ICF was signed
  • Expanded Disability Status Scale (EDSS) score 0.0 to 5.0 (inclusive) at Screening
  • Greater than or equal to (>=) 2 MS attacks (first episode or relapse) occurring in the 24 months prior to the date the ICF was signed, with >=1 attack in the 12 months prior to the date the ICF was signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other Genzyme-approved health-care provider and the objective signs could be identified retrospectively
  • >=1 MS relapse during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for >=6 months within 10 years of the date the ICF was signed
  • MRI scan demonstrating white matter lesions attributable to MS and meeting at least 1 of the following criteria, as determined by the neurologist or a radiologist: >=9 time constant 2 (T2) lesions at least 3 millimeter (mm) in any axis; a gadolinium- (Gd-) enhancing lesion at least 3 mm in any axis plus >=1 brain T2 lesions; and a spinal cord lesion consistent with MS plus >=1 brain T2 lesion

Exclusion Criteria:

  • Received prior therapy with alemtuzumab
  • Current participation in another clinical study or previous participation in CAMMS323 (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, CARE-MS I)
  • Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months. Participants who received one of these medications more than 6 months before the date the ICF was signed were eligible for study entry if approval was granted by Genzyme
  • Any progressive form of MS
  • History of malignancy (except basal skin cell carcinoma)
  • CD4 +, CD8 +, CD19 + (that is, absolute CD3 + CD4 + , CD3 + CD8 + , or CD19 + /mm 3 ) count, absolute neutrophil count less than (<) lower limit of normal (LLN) at screening; if abnormal cell count(s) returned to within normal limits (WNL), eligibility could be reassessed
  • Known bleeding disorder (for example, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, or clotting factor deficiency)
  • Significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
  • Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (that is, above the LLN)
  • Active infection or at high risk for infection
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Please refer to this study by its identifier: NCT00548405

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United States, Alabama
North Central Neurology Associates, P.C.
Cullman, Alabama, United States
United States, Arizona
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Hope Research Institute
Phoenix, Arizona, United States
Mayo Clinic Arizona, Department of Neurology
Scottsdale, Arizona, United States
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, United States
United States, California
East Bay Physicians Medical Group/Sutter East Bay Medical Foundation
Berkeley, California, United States
Neurology Center of North Orange County
La Habra, California, United States
Department of Neurology, Keck School of Medicine, University of Southern California
Los Angeles, California, United States
Neuro-Therapeutics Inc.
Pasadena, California, United States
Neuro-Therapeutics, Inc
Pasadena, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Stanford University School of Medicine
Stanford, California, United States
United States, Colorado
University of Colorado Hospital, Anschutz Outpatient Pavilioin
Aurora, Colorado, United States
Neurological Consultants
Denver, Colorado, United States
Advanced Neurosciences Research
Fort Collins, Colorado, United States
United States, Connecticut
Yale University
New Haven, Connecticut, United States
United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States
United States, Florida
University of Florida Neuroscience Institute
Jacksonville, Florida, United States
Neurology Associates, P.A.
Maitland, Florida, United States
Neurological Associates
Pompano Beach, Florida, United States
Negroski, Stein, Sutherland and Hanes Neurology
Sarasota, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
University of South Florida, Department of Neurology
Tampa, Florida, United States
United States, Georgia
Emory University, Department of Neurology
Atlanta, Georgia, United States
Shepherd Center, Inc.
Atlanta, Georgia, United States
United States, Idaho
Idaho Falls Multiple Sclerosis Center, PLLC
Idaho Falls, Idaho, United States
United States, Illinois
University of Chicago Medical Center, Department of Neurology
Chicago, Illinois, United States
Consultants in Neurology, Ltd
Northbrook, Illinois, United States
United States, Indiana
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Indiana University School of Medicine, Department of Neurology
Indianapolis, Indiana, United States
Josephson Wallack Munshower Neurology P.C.
Indianapolis, Indiana, United States
United States, Iowa
Iowa Health Physicians
Des Moines, Iowa, United States
Ruan Neurology Clinic and Research Center
Des Moines, Iowa, United States
United States, Kansas
University of Kansas Medical Center, Department of Neurology
Kansas City, Kansas, United States
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States
United States, Kentucky
Associates in Neurology, PSC
Lexington, Kentucky, United States
University of Louisville Research Foundation
Louisville, Kentucky, United States
United States, Louisiana
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
United States, Massachusetts
Partners Multiple Sclerosis Center/Brigham and Women's Hospital
Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
United States, Michigan
University of Michigan Department of Neurology
Ann Arbor, Michigan, United States
Wayne State University, School of Medicine, Department of Neurology
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Spectrum Health Medical Group, Neurology (Previously known as Michigan Medical P.C., Neurology)
Grand Rapids, Michigan, United States
Michigan Neurology Associates, P.C.
St. Clair Shores, Michigan, United States
Northern Michigan Neurology
Traverse City, Michigan, United States
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States
United States, Missouri
Neurology Consultants of Kansas City, Inc.
Kansas City, Missouri, United States
United States, Montana
Montana Neurobehavioral Specialists
Missoula, Montana, United States
United States, Nevada
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Renown Institute for Neurosciences / Renown regional Medical Center
Reno, Nevada, United States
United States, New Hampshire
Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
United States, New Jersey
MS Center at Holy Name Hospital
Teaneck, New Jersey, United States
United States, New Mexico
University of New Mexico, Health Sciences Center, MS Specialty Clinic
Alburquerque, New Mexico, United States
United States, New York
Empire Neurology, PC
Latham, New York, United States
Winthrop University Hospital, Clinical Trials Center
Mineola, New York, United States
Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis
New York, New York, United States
Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.
Patchogue, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical University, Department of Neurology
Syracuse, New York, United States
United States, North Carolina
University of North Carolina-Chapel Hill, Department of Neurology
Chapel Hill, North Carolina, United States
Wake Forest University Health Science, Department of Neurology
Winston-Salem, North Carolina, United States
United States, Ohio
Cleveland Clinic Foundation, Mellen Center
Cleveland, Ohio, United States
Neurology Specialists, Inc.
Dayton, Ohio, United States
Oak Clinic for Multiple Sclerosis
Uniontown, Ohio, United States
United States, Oklahoma
MS Center of Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Lehigh Valley Hospital, Neuroscience and Pain Research
Allentown, Pennsylvania, United States
Northshore Clinical Associates
Erie, Pennsylvania, United States
University of Pittsburgh, Kaufmann Medical Building
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
The Neurology Foundation, Inc.
Providence, Rhode Island, United States
United States, Tennessee
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Advanced Neurosciences Institute
Franklin, Tennessee, United States
Biomedical Research Alliance of NY, LLC
Franklin, Tennessee, United States
Hope Neurology PC
Knoxville, Tennessee, United States
Vanderbilt Multiple Sclerosis Center
Nashville, Tennessee, United States
United States, Texas
Clinical Center for Multiple Sclerosis
Dallas, Texas, United States
Central Texas Neurology
Round Rock, Texas, United States
Integra Clinical Research
San Antonio, Texas, United States
Neurology Center of San Antonio
San Antonio, Texas, United States
United States, Virginia
MS Center of Greater Washington, P.C.
Vienna, Virginia, United States
United States, Washington
Swedish Neuroscience Institute
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Rockwood Clinical Research Center
Spokane, Washington, United States
Buenos Aires, Argentina
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia
Australia, Queensland
The Wesley Research Institute
Auchenflower, Queensland, Australia, 4066
Griffith School of Medicine, Gold Coast Campus, Griffith University
Southport, Queensland, Australia
Australia, South Australia
Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department
Woodville South, South Australia, Australia
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Australia, Victoria
St. Vincent's Hospital, MS Education & Research, Department of Clinical Neurosciences
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Royal Melbourne Hospital, Department of Neurology
Parkville, Victoria, Australia, 3050
Concord Repatriation General Hospital, Neurosciences Department
Concord, Australia
Southern Neurology
Kogarah, Australia
Liverpool Hospital, Neurology Department
Liverpool, Australia, 2170
AKH Wien, Universitätsklinikum für Neurologie
Wien, Austria
Cliniques Universitaires Saint-Luc, Neurology
Brussel, Belgium
CHU Ourthe Amblève, Neurology
Esneux, Belgium
University Hospital Leuven, Campus Gasthuisberg, Neurology
Leuven, Belgium
Hospital da Restauracao
Recife, PE, Brazil
Hospital Sao Lucas PUC-RS
Porto Alegre, RS, Brazil
Irmandade da Santa Casa de Misericordia de Sao Paulo
Sao Paulo, Brazil
Hospital de Clínicas USP
Sao Paulo, Brazil
Canada, British Columbia
UBC Hospital
Vancouver, British Columbia, Canada
Canada, Ontario
Multiple Sclerosis Clinic, Connell 7, Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre- University Hospital
London, Ontario, Canada
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Canada, Quebec
Centre de Sante et de Services Sociaux de Gatineau-Hull Hospital
Gatineau, Quebec, Canada
Clinique Neuro rive-sud, Recherche sepmus inc
Greenfield park, Quebec, Canada
Hospital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Clinical Hospital Centre Rijeka, Clinic for Neurology
Rijeka, Croatia
General Hospital Varazdin, Department of neurology
Varazdin, Croatia
Clinical Hospital Centre Zagreb
Zagreb, Croatia
Clinical Hospital Sestre Milosrdnice
Zagreb, Croatia
General Hospital " Sveti Duh", Department of neurology
Zagreb, Croatia
Czech Republic
MS Center, Department of Neurology
Hradec Kralove, Czech Republic
St. Anne's University Hospital Brno
Pekarska, Czech Republic
Department of Neurology 1st Faculty of Medicine and General Teaching Hospital, MS Center
Praha 2, Czech Republic
Krajska zdravotni a.s. - Hospital Teplice
Teplice, Czech Republic
Århus Universitetshospital, Scleroseklinikken, Århus Sygehus
Aarhus, Denmark
Scleroseklinikken, Rigshospitalet
København, Denmark
Odense University Hospital
Odense, Denmark
CHU Clermont-Ferrand, Hôpital Gabriel Montpied
Clermont-Ferrand, France
Hôpital General, Service de Neurologie
Dijon Cedex, France
Hospital Roger Salengro
Lille Cedex, France
Hôpital Pitié Salpétrière, Service de Neurologie
Paris, France
Sevice de Neurologie
Rennes Cedex, France
Hôpital Civil, Departement de Neurologie
Strasbourg Cedex, France
Krankenhaus Hohe Warte, Betriebsstätte der Bayreuth
Bayreuth, Germany
Judisches Krankenhaus Berlin
Berlin, Germany
Neurologisches Fachzentrum Berlin
Berlin, Germany
Neurologische Universitätsklinik Bonn
Bonn, Germany
Multiple Sklerose Zentrum am, Zentrum für klinische Neurowissenschaften, Neurologische Uniklinik Dresden
Dresden, Germany
Asklepios Klinic Barmbek
Hamburg, Germany
Medizinische Hochshule Hannover
Hannover, Germany
Oberhavelkliniken Hennigsdorf
Hennigsdorf, Germany
Klinikum Ingolstadt, Neurologische Klinik
Ingolstadt, Germany
Klinikum Rechts der Isar, Klinik für Neurologie
Muenchen, Germany
Klinik und Poliklinik fur Neurologie der Universitat Rockstock
Rostock, Germany
Universitatsklinik Ulm
Ulm, Germany
Fachkrankenhaus Hubertusburg
Wermsdorf, Germany
Hadassah Medical Center Ein Karem
Jerusalem, Israel
Tel Aviv Sourasky Medical Center, Department of Neurology
Tel Aviv, Israel
Sheba Medical Centre
Tel Hashomer, Israel
Ospedale Binaghi - Centro Sclerosi Multipla
Cagliari, Italy
Ospedale S. Antonio Abate di Gallarate
Gallarate, Italy
Università di Genova Dipartimento di Neuroscienze Oftalmologia e Genetica
Genova, Italy
Ospedale Civile di Brescia c/o Ospedale Richiedei, Centro di riferimento per la Sclerosi Multiple
Montichiari, Italy
Ospedale San Luigi di Orbassano
Orbassano, Italy
Azienda Ospedaliera Sant'Andrea Neurologia
Roma, Italy
Hospital Medica Sur CIF-BIOTEC
Delegacion, Tlalpan, Mexico
Unidad de Investigación en Salud de Chihuahua, S.C.
Chihuahua, Mexico
Hospital Angeles del Pedregal; Camino a Santa Teresa
Mexico City, Mexico
Jeroen Bosch Ziekenhuis
Hertogenbosch, Netherlands
Orbis Medisch Centrum, Department of Neurology
Sittard, Netherlands
Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz
Lodz, Poland
Independent Public Teaching Hospital No. 4 in Lublin
Lublin, Poland
Heliodor Swiecicki Teaching Hospital of the Poznan, University of Medical Sciences
Poznan, Poland
Russian Federation
Research Medical Complex "Your Health" Ltd
Kazan, Russian Federation
Institution of the Russian Academy of Medical Sciences, "Neurology Scientific Center under RAMS"
Moscow, Russian Federation
Moscow State Medical Institution City Clinical Hospital #11, Moscow City Center for Multiple Sclerosis
Moscow, Russian Federation
Moscow State Public Medical Institution, City Clinical Hospital #11
Moscow, Russian Federation
Municipal Treatment and Prevention Institution, "City Hospital #33"
Nizhniy Novgorod, Russian Federation
Federal State Institution: Siberian District Medical Center
Novosibirsk, Russian Federation
State Medical Institution, "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
Samara, Russian Federation
St.Petersburg State Medical Institution, "Nikolayevskaya Hospital"
St. Petersburg, Russian Federation
St. Petersburg Pavlov State Medical University, Department of Neurology and Neurosurgery with a Clinic
St. Petersburg, Russian Federation
St.Petersburg State Medical Institution, "City Multispecialty Hospital #2"
St. Petersburg, Russian Federation
Institution of the Russian Academy of Sciences, "Institute of the Human Brain n.a. N.P. Bekhtereva within the Russian Academy of Sciences"
St. Petersburg, Russian Federation
Clinic of Neurology, Clinical Centre of Serbia
Belgrade, Serbia
Military Medical Academy
Belgrade, Serbia
Clinical Centre of Kragujevac
Kragujevac, Serbia
Clinical Centre Vojvodina Institute of Neurology
Novi Sad, Serbia
Servicio de Neurología Hospital Vall d'Hebron Paseo de Vall d'Hebron
Barcelona, Spain
Servicio de Neurología Hospital Clínico San Carlos
Madrid, Spain
Servicio de Neurología Hospital Carlos Haya
Malaga, Spain
Servicio de Neurología Hospital Virgen de la Macarena
Sevilla, Spain
Sahlgrenska University Hospital, Neurologkliniken
Gothenburg, Sweden
Norrlands Universitets sjukhus
Umea, Sweden
Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine
Kharkov, Ukraine
Kyiv Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System
Kyiv, Ukraine
Danylo Halytsky Lviv National Medical University, Department of Neurology
Lviv, Ukraine
United Kingdom
Department Of Neurosciences, Addenbrookes Hospital
Cambridge, England, United Kingdom
Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science Barts and The London School of Medicine and Dentistry
London, England, United Kingdom
Frenchay Hospital
Bristol, United Kingdom
Salford Royal NHS Foundation Trust, Clinical Trials Unit
Salford, United Kingdom
Department of Neurology Glossop Road, Royal Hallamshire Hospital
Sheffield, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi ( Genzyme, a Sanofi Company ) Identifier: NCT00548405     History of Changes
Other Study ID Numbers: CAMMS32400507, 2007-001162-32, CAMMS324,, ISRCTN70702834, ACTRN12608000426381, NTR1469, CARE-MS II
Study First Received: October 22, 2007
Results First Received: November 17, 2014
Last Updated: January 6, 2015
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Ministry for Health Family and Youth
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Croatia: Agency for Medicinal Product and Medical Devices
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Medical Ethics Review Committee (METC)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sanofi:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta 1a
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on October 06, 2015