Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
NCT ID: NCT00548405
Last Updated: 2017-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
840 participants
INTERVENTIONAL
2007-10-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Alemtuzumab 12 mg
Alemtuzumab (Lemtrada™) 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.
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.
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.
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.
Interferon Beta-1a
Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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North Central Neurology Associates, P.C.
Cullman, Alabama, United States
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
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
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
Yale University
New Haven, Connecticut, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
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
Emory University, Department of Neurology
Atlanta, Georgia, United States
Shepherd Center, Inc.
Atlanta, Georgia, United States
Idaho Falls Multiple Sclerosis Center, PLLC
Idaho Falls, Idaho, United States
University of Chicago Medical Center, Department of Neurology
Chicago, Illinois, United States
Consultants in Neurology, Ltd
Northbrook, Illinois, United States
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
Iowa Health Physicians
Des Moines, Iowa, United States
Ruan Neurology Clinic and Research Center
Des Moines, Iowa, United States
University of Kansas Medical Center, Department of Neurology
Kansas City, Kansas, United States
MidAmerica Neuroscience Institute
Lenexa, Kansas, United States
Associates in Neurology, PSC
Lexington, Kentucky, United States
University of Louisville Research Foundation
Louisville, Kentucky, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Partners Multiple Sclerosis Center/Brigham and Women's Hospital
Boston, Massachusetts, United States
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan Department of Neurology
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Wayne State University, School of Medicine, Department of Neurology
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.
Saint Clair Shores, Michigan, United States
Northern Michigan Neurology
Traverse City, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Neurology Consultants of Kansas City, Inc.
Kansas City, Missouri, United States
Montana Neurobehavioral Specialists
Missoula, Montana, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Renown Institute for Neurosciences / Renown regional Medical Center
Reno, Nevada, United States
Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
MS Center at Holy Name Hospital
Teaneck, New Jersey, United States
University of New Mexico, Health Sciences Center, MS Specialty Clinic
Albuquerque, New Mexico, United States
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
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
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
MS Center of Oklahoma
Oklahoma City, Oklahoma, United States
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
The Neurology Foundation, Inc.
Providence, Rhode Island, United States
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
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
MS Center of Greater Washington, P.C.
Vienna, Virginia, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Rockwood Clinical Research Center
Spokane, Washington, United States
DIABAID
Buenos Aires, , Argentina
Westmead Hospital
Westmead, New South Wales, Australia
The Wesley Research Institute
Auchenflower, Queensland, Australia
Griffith School of Medicine, Gold Coast Campus, Griffith University
Southport, Queensland, Australia
Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department
Woodville South, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
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
Concord Repatriation General Hospital, Neurosciences Department
Concord, , Australia
Southern Neurology
Kogarah, , Australia
Liverpool Hospital, Neurology Department
Liverpool, , Australia
AKH Wien, Universitätsklinikum für Neurologie
Vienna, , Austria
Cliniques Universitaires Saint-Luc, Neurology
Brussels, , Belgium
CHU Ourthe Amblève, Neurology
Esneux, , Belgium
University Hospital Leuven, Campus Gasthuisberg, Neurology
Leuven, , Belgium
Hospital da Restauracao
Recife, Pernambuco, Brazil
Hospital Sao Lucas PUC-RS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas USP
São Paulo, , Brazil
Irmandade da Santa Casa de Misericordia de Sao Paulo
São Paulo, , Brazil
UBC Hospital
Vancouver, British Columbia, Canada
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
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
Varaždin, , Croatia
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Clinical Hospital Sestre Milosrdnice
Zagreb, , Croatia
General Hospital " Sveti Duh", Department of neurology
Zagreb, , Croatia
MS Center, Department of Neurology
Hradec Králové, , Czechia
St. Anne's University Hospital Brno
Pekarska, , Czechia
Department of Neurology 1st Faculty of Medicine and General Teaching Hospital, MS Center
Prague, , Czechia
Krajska zdravotni a.s. - Hospital Teplice
Teplice, , Czechia
Århus Universitetshospital, Scleroseklinikken, Århus Sygehus
Aarhus, , Denmark
Scleroseklinikken, Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
CHU Clermont-Ferrand, Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Hôpital General, Service de Neurologie
Dijon, , France
Hospital Roger Salengro
Lille, , France
Hôpital Pitié Salpétrière, Service de Neurologie
Paris, , France
Sevice de Neurologie
Rennes, , France
Hôpital Civil, Departement de Neurologie
Strasbourg, , 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
Hanover, , Germany
Oberhavelkliniken Hennigsdorf
Hennigsdorf, , Germany
Klinikum Ingolstadt, Neurologische Klinik
Ingolstadt, , Germany
Klinikum Rechts der Isar, Klinik für Neurologie
München, , 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 Litwinsky, , 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
Unidad de Investigación en Salud de Chihuahua, S.C.
Chihuahua City, Chihuahua, Mexico
Hospital Medica Sur CIF-BIOTEC
Delegacion, Tlalpan, Mexico
Hospital Angeles del Pedregal; Camino a Santa Teresa
Mexico City, , Mexico
Jeroen Bosch Ziekenhuis
's-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
Research Medical Complex "Your Health" Ltd
Kazan', , Russia
Institution of the Russian Academy of Medical Sciences, "Neurology Scientific Center under RAMS"
Moscow, , Russia
Moscow State Medical Institution City Clinical Hospital #11, Moscow City Center for Multiple Sclerosis
Moscow, , Russia
Moscow State Public Medical Institution, City Clinical Hospital #11
Moscow, , Russia
Municipal Treatment and Prevention Institution, "City Hospital #33"
Nizhny Novgorod, , Russia
Federal State Institution: Siberian District Medical Center
Novosibirsk, , Russia
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, , Russia
St. Petersburg Pavlov State Medical University, Department of Neurology and Neurosurgery with a Clinic
Saint Petersburg, , Russia
St.Petersburg State Medical Institution, "City Multispecialty Hospital #2"
Saint Petersburg, , Russia
St.Petersburg State Medical Institution, "Nikolayevskaya Hospital"
Saint Petersburg, , Russia
State Medical Institution, "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
Samara, , Russia
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
Málaga, , Spain
Servicio de Neurología Hospital Virgen de la Macarena
Seville, , Spain
Sahlgrenska University Hospital, Neurologkliniken
Gothenburg, , Sweden
Norrlands Universitets sjukhus
Umeå, , Sweden
Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine
Kharkiv, , 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
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
Countries
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References
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Arnold DL, Fisher E, Brinar VV, Cohen JA, Coles AJ, Giovannoni G, Hartung HP, Havrdova E, Selmaj KW, Stojanovic M, Weiner HL, Lake SL, Margolin DH, Thomas DR, Panzara MA, Compston DA; CARE-MS I and CARE-MS II Investigators. Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon beta-1a in MS. Neurology. 2016 Oct 4;87(14):1464-1472. doi: 10.1212/WNL.0000000000003169. Epub 2016 Sep 2.
Grafals M, Smith B, Murakami N, Trabucco A, Hamill K, Marangos E, Gilligan H, Pomfret EA, Pomposelli JJ, Simpson MA, Azzi J, Najafian N, Riella LV. Immunophenotyping and efficacy of low dose ATG in non-sensitized kidney recipients undergoing early steroid withdrawal: a randomized pilot study. PLoS One. 2014 Aug 11;9(8):e104408. doi: 10.1371/journal.pone.0104408. eCollection 2014.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-001162-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAMMS324,
Identifier Type: -
Identifier Source: secondary_id
ISRCTN70702834
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTRN12608000426381
Identifier Type: REGISTRY
Identifier Source: secondary_id
NTR1469
Identifier Type: REGISTRY
Identifier Source: secondary_id
CARE-MS II
Identifier Type: OTHER
Identifier Source: secondary_id
CAMMS32400507
Identifier Type: -
Identifier Source: org_study_id
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