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| Sponsor: | Genzyme |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00548405 |
Purpose
The purpose of this study is to establish the efficacy and safety of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif® (interferon beta-1a). The study will enroll patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI. Patients will have monthly laboratory tests and comprehensive testing every 3 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Biological: alemtuzumab Biological: interferon beta-1a (Rebif®) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing 2 Annual Cycles of IV 12 mg and 24 mg Alemtuzumab to 3x Weekly SC Interferon Beta-1a (Rebif®) in Relapsing-Remitting Multiple Sclerosis Patients Who Have Relapsed on Therapy |
| Enrollment: | 840 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| alemtuzumab 12 mg: Experimental |
Biological: alemtuzumab
12 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 12 mg per day administered through IV, once a day for 3 consecutive days at Month 12
|
| alemtuzumab 24mg: Experimental |
Biological: alemtuzumab
24 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 24 mg per day administered through IV, once a day for 3 consecutive days at Month 12 Note: The 24 mg alemtuzumab dose is closed to enrollment.
|
| interferon beta-1a (Rebif ®): Active Comparator |
Biological: interferon beta-1a (Rebif®)
44 mcg administered 3-times weekly by SC injections for 2 years
|
Every patient will receive active treatment; there is no placebo. Patients will be randomized in a 2:2:1 ratio to receive 12 mg alemtuzumab, 24 mg alemtuzumab or Rebif® (ie, 2 given 12 mg or 24 mg alemtuzumab for every 1 given Rebif®). Alemtuzumab will be administered in two annual cycles, once at the beginning of the study and again 1 year later. Rebif® will be self-injected 3 times per week for 2 years. All patients will be required to return to their study site every 3 months for neurologic assessment. In addition, safety-related laboratory tests will be performed at least monthly. Participation in this study will end 2 years after the start of treatment for each patient. Additionally, all patients who receive alemtuzumab will be followed in an extension study (CAMMS03409 NCT00930553) for safety and efficacy assessments. Patients who receive Rebif® and complete 2 years on study may be eligible to receive alemtuzumab in an extension study.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| North Central Neurology Associates, P.C. | |
| Cullman, Alabama, United States | |
| United States, Arizona | |
| Barrow Neurology Clinics at 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 | |
| Neuro-Therapeutics, Inc | |
| Pasadena, 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 | |
| UC Davis Medical Center | |
| Sacramento, California, United States | |
| Stanford University Medical Center | |
| Stanford, California, United States | |
| East Bay Physicians Medical Group/Sutter East Bay Medical Foundation | |
| Berkeley, California, United States | |
| United States, Colorado | |
| University of Colorado Hospital Anschutz Outpatient Pavilioin | |
| Aurora, Colorado, United States | |
| Colorado Neurological Consultants | |
| Denver, Colorado, United States | |
| Advanced Neurosciences Research LLC | |
| Fort Collins, Colorado, United States | |
| United States, Connecticut | |
| Yale University Multiple Sclerosis Center | |
| 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 | |
| University of South Florida Medical Clinics | |
| Tampa, 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 | |
| Neurology Associates, P.A. | |
| Maitland, Florida, United States | |
| United States, Georgia | |
| Shephard Center Inc | |
| Atlanta, Georgia, United States | |
| The Emory Clinic | |
| Atlanta, Georgia, United States | |
| United States, Idaho | |
| Eastern Idaho Neurological Associates | |
| Idaho Falls, Idaho, United States | |
| United States, Illinois | |
| University of Chicago Medical Center | |
| 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 Hospital | |
| Indianapolis, Indiana, United States | |
| United States, Iowa | |
| Ruan Neurology Clinic and Research Center | |
| Des Moines, Iowa, United States | |
| Iowa Health Physicians | |
| Des Moines, Iowa, United States | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| 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, Kentucky Neuroscience Research | |
| Louisville, Kentucky, United States | |
| United States, Massachusetts | |
| Caritas St. Elizabeth's Hospital Medical Center | |
| Boston, Massachusetts, United States | |
| Springfield Neurology Associates, LLC | |
| Springfield, Massachusetts, United States | |
| UMass Memorial Health Care | |
| Worcester, Massachusetts, United States | |
| United States, Michigan | |
| University of Michigan Department of Neurology | |
| Ann Arbor, Michigan, United States | |
| Wayne State University | |
| Detroit, Michigan, United States | |
| Michigan Medical, PC | |
| Grand Rapids, Michigan, United States | |
| Michigan Neurology Associates, P.C. | |
| St. Clair Shores, Michigan, United States | |
| North Michigan Neurology | |
| Traverse City, Michigan, United States | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States | |
| United States, Mississippi | |
| Tupelo Neurology Clinic, PA | |
| Tupelo, Mississippi, United States | |
| United States, Missouri | |
| Saint Luke's Hospital | |
| Kansas City, Missouri, United States | |
| Minor Procedures Center | |
| St. Louis, Missouri, United States | |
| United States, Montana | |
| Montana Neurobehavioral Specialists | |
| Missoula, Montana, United States | |
| United States, Nevada | |
| Neurology Physicians | |
| Reno, Nevada, United States | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical 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 Hospital | |
| Albuquerque, New Mexico, United States | |
| United States, New York | |
| Empire Neurology PC | |
| Latham, New York, United States | |
| Winthrop University Hospital | |
| Mineola, New York, United States | |
| NYU Hospital of Joint Diseases | |
| New York, 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 | |
| Syracuse, New York, United States | |
| United States, North Carolina | |
| University of North Caroline-Chapel Hill, Department of Neurology | |
| Chapel Hill, North Carolina, United States | |
| Wake Forest University Health Science | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| The Cleveland Clinic Mellen Center | |
| Cleveland, Ohio, United States | |
| The Ohio State University Medical Center, Multiple Sclerosis Center | |
| Columbus, Ohio, United States | |
| Oak Clinic for Multiple Sclerosis | |
| Uniontown, Ohio, United States | |
| United States, Oklahoma | |
| MS Center of Oklahoma, Mercy Health Center | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital, Neuroscience and Pain Research | |
| Allentown, Pennsylvania, United States | |
| North Shore Clinical Associates | |
| Erie, Pennsylvania, United States | |
| Kaufmann Medical Building, Department of Neurology | |
| Pittsburgh, Pennsylvania, United States | |
| University of Pittsburg | |
| Pittsburg, Pennsylvania, United States | |
| United States, Rhode Island | |
| Rhode Island Hospital and The Neurology Foundation, Inc | |
| Providence, Rhode Island, United States | |
| United States, Tennessee | |
| Neurology Clinic, P.C. | |
| Cordova, Tennessee, United States | |
| Sibyl Wray, MD Neurology, PC | |
| Knoxville, Tennessee, United States | |
| Advanced Neurosciences Institute | |
| Nashville, Tennessee, United States | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States | |
| Central Texas Neurology Consultants | |
| Round Rock, Texas, United States | |
| Neurology Center of San Antonio | |
| San Antonio, Texas, United States | |
| Integra Clinical Research | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| MS Center of Greater Washington | |
| Vienna, Virginia, United States | |
| United States, Washington | |
| Swedish Neuroscience Institute | |
| Seattle, Washington, United States | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States | |
| Argentina, Capital Federal- Buenos Aires | |
| DIABAID | |
| Paraguay, Capital Federal- Buenos Aires, Argentina | |
| Australia | |
| Concord Repatriation General Hospital | |
| Concord, Australia | |
| Southern Neurology | |
| Kogarah, Australia | |
| Liverpool Hospital | |
| Liverpool, Australia, 2170 | |
| St. Vincent's Hospital | |
| Melbourne, Australia | |
| Austin Health | |
| Victoria, Australia | |
| Westmead Hospital | |
| Westmead, Australia | |
| Australia, Queensland | |
| The Wesley Research Institute | |
| Auchenflower, Queensland, Australia, 4066 | |
| Griffith University and Gold Coast Hospital | |
| Southport, Queensland, Australia | |
| Australia, South Australia | |
| The Queen Elizabeth Hospital | |
| Woodville South, South Australia, Australia | |
| Australia, Tasmania | |
| Royal Hobart Hospital | |
| Hobart, Tasmania, Australia, 7000 | |
| Australia, Victoria | |
| Royal Melbourne Hospital | |
| Parkville, Victoria, Australia, 3050 | |
| Belgium | |
| UCL Saint Luc | |
| Brussels, Belgium | |
| CHU Ourthe Ambleve | |
| Esneux, Belgium | |
| UZ Leuven Gasthuisberg | |
| Leuven, Belgium | |
| Brazil | |
| Hospital das Clinicas da Faculdade de Medicina da USP | |
| Sao Paulo, Brazil | |
| Brazil, PE | |
| Hospital da Restauracai | |
| Recife, PE, Brazil | |
| Brazil, RS | |
| Hospital Sao Lucas da PUC-RS | |
| Porto Alegre, RS, Brazil | |
| Brazil, Sao Paulo | |
| Irmandade da Santa Casa de Misericordia de Sao Paulo | |
| Vila Buarque, Sao Paulo, Brazil | |
| Canada, British Columbia | |
| UBC Hospital 2211 Westbrook Mall | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Multiple Sclerosis Clinic, Kingston General Hospital | |
| Kingston, Ontario, Canada | |
| London Health Sciences Centre- University Hospital | |
| London, Ontario, Canada | |
| Ottawa Hospital-General Campus | |
| Ottawa, Ontario, Canada | |
| Canada, Quebec | |
| Clinique de neurologie de l'Outaouais | |
| Gatineau, Quebec, Canada | |
| Clinique Neuro rive-sud, Recherche sepmus inc | |
| Greenfield park, Quebec, Canada | |
| Hospital Maisonneuve-Rosemont | |
| Montreal, Quebec, Canada | |
| Croatia | |
| Clinical Hospital Centre Rijeka | |
| Rijeka, Croatia | |
| General Hospital Varazdin | |
| Varazdin, Croatia | |
| Clinical Hospital Centre Zagreb | |
| Zagreb, Croatia | |
| Clinical Hospital Sveti Duh | |
| Zagreb, Croatia | |
| Clinical Hospital Sestre Milosrdnice | |
| Zagreb, Croatia | |
| Czech Republic | |
| University Hospital Hradec, Kralove | |
| Hradec Kralove, Czech Republic | |
| St. Anne's University Hospital Brno | |
| Pekarska, Czech Republic | |
| General University Hospital in Prague | |
| Prague, Czech Republic | |
| Denmark | |
| Aarhus Sygehus | |
| Aarhus, Denmark | |
| Righospitalet | |
| Copenhagen, Denmark | |
| Odense University Hospital | |
| Odense, Denmark | |
| France | |
| Hopital Neurologique | |
| Bron Cedex, France | |
| Hospital General Service de Neurologie | |
| Cedex, France | |
| Hospital Roger Salengro | |
| Cedex, France | |
| Group Hospitalier Pitie Salpetriere | |
| Cedex, France | |
| CHU Pontchaillou | |
| Rennes, France | |
| France, Cedex | |
| Hopital Civil | |
| Strasbourg, Cedex, France | |
| Germany | |
| Klinik fur Neurologie Universitatsklinikum Bon | |
| Bonn, Germany | |
| Neurologische Universitasklink | |
| Dresden, Germany | |
| Neurologische Klinik | |
| Dusseldorf, Germany | |
| Medizinische Hochshule Hannover | |
| Hannover, Germany | |
| Krankenhaus Henningsdorf Abteilung fur Neurologie | |
| Henningsdorf, Germany | |
| Universitat Leipzig | |
| Leipzig, Germany | |
| Neurologiche Klinik und Poliklinik der TU Muenchen | |
| Muenchen, Germany | |
| Klinik und Poliklinik fur Neurologie der Universitat Rockstock | |
| Rockstock, Germany | |
| Universitatsklinik Ulm | |
| Ulm, Germany | |
| Fachkrankenhaus Hubertusburg GmbH | |
| Wemsdorf, Germany | |
| Israel | |
| Haddasah Medical Organisation | |
| Jerusalem, Israel | |
| Souraski TA Medical Centre | |
| Tel Aviv, Israel | |
| Sheba Medical Centre | |
| Tel Hashomer, Israel | |
| Italy | |
| Azienda Ospidaliera S. Antonio Abate di Gallarate | |
| Gallarate, Italy | |
| IRCCS San Raffaele Hospital | |
| Milan, Italy | |
| Spedali Civili Presidio di Montichiari | |
| Montichiari, Italy | |
| A.O.U.S. Luigi Gonzaga di Orbassano | |
| Orbassano, Italy | |
| Ospedale San Luigi Gonzaga | |
| Orbassano, Italy | |
| Azienda Ospidaliera S. Antonio Abate di Gallarate | |
| Rome, Italy | |
| Mexico | |
| Hospital Angeles del Pedregal; Camino a Santa Teresa | |
| Mexico City, Mexico | |
| Ortiz Mena 2200 Col. Las Palmas | |
| Chihuahua, Mexico | |
| Mexico, Tlalpan | |
| Hospital Medica Sur | |
| Delegacion, Tlalpan, Mexico | |
| Netherlands | |
| Jeroen Bosch Ziekenhuis | |
| Den Bosch, Netherlands | |
| Faculty of Health Medicine and Life Science | |
| Sittard, Netherlands | |
| Poland | |
| Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny nr 1 UM w Lodzi | |
| Lodz, Poland | |
| Samodzielny Publiczny Szpital Kliniczny nr 4 | |
| Lublin, Poland | |
| Szpital Kliniczny im. Helidora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu | |
| Poznan, Poland | |
| Russian Federation | |
| Research Medical Complex "Your Health" Ltd | |
| Kazan, Russian Federation | |
| State Institution Scientific Neurology Center RAMS | |
| Moscow, Russian Federation | |
| Samara Regional Clinical Hospital n.a. Kalinin | |
| Samara, Russian Federation | |
| Moscow City Hospital #11 | |
| Moscow, Russian Federation | |
| Municipal City Hospital #33 | |
| Nizhny Novgorod, Russian Federation | |
| Siberian District Medical Center | |
| Novosibirsk, Russian Federation | |
| Russian State Medical University | |
| Moscow, Russian Federation | |
| Nikolaevskaya Hospital | |
| St. Petersburg, Russian Federation | |
| St. Petersburg General Hospital No.2 | |
| St. Petersburg, Russian Federation | |
| St. Petersburg Pavlov State Medical University | |
| St. Petersburg, Russian Federation | |
| Insitute of Human Brain RAS | |
| St. Petersburg, Russian Federation | |
| Serbia | |
| Clinical Centre of Serbia | |
| Belgrade, Serbia | |
| Military Medical Academy | |
| Belgrade, Serbia | |
| Clinical Centre of Kragujevac | |
| Kragujevac, Serbia | |
| Clinical Centre Vjovodina Institute of Neurology | |
| Novi Sad, Serbia | |
| Spain | |
| Hospital Vall d'Hebron | |
| Barcelona, Spain | |
| Hospital Clinico Universtitario San Carlos | |
| Madrid, Spain | |
| Hospital Carlos Haya | |
| Malaga, Spain | |
| Hospital University Virgen Macarena | |
| Sevilla, Spain | |
| Sweden | |
| SU/Ostra sjukhuset Forskningsenheten | |
| Gothenburg, Sweden | |
| Norrlands Universitets sjukhus | |
| Umea, Sweden | |
| Ukraine | |
| Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine | |
| Kharkov, Ukraine | |
| Kiev Municipal Clinical Hospital #4 | |
| Kiev, Ukraine | |
| Danylo Halytsky National Medical University | |
| Lviv, Ukraine | |
| United Kingdom | |
| Institute of Clinical Neurosciences Frenchay Hospital | |
| Bristol, United Kingdom | |
| Salford Royal Hospital | |
| Salford, United Kingdom | |
| Royal Hallamshire Hospital | |
| Sheffield, United Kingdom | |
| United Kingdom, England | |
| Addenbrooke's Hospital, University Neurology unit | |
| Cambridge, England, United Kingdom | |
| The Royal London Hospital | |
| London, England, United Kingdom | |
| Study Director: | Medical Monitor | Genzyme Coorporation |
More Information
| Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
| Study ID Numbers: | CAMMS32400507, CAMMS324,, ISRCTN70702834,, ACTRN12608000426381,, NTR1469 |
| Study First Received: | October 22, 2007 |
| Last Updated: | October 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00548405 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration; Czech Republic: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: State Pharmacological Center - Ministry of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Mexico: Federal Commission for Sanitary Risks Protection; Brazil: National Health Surveillance Agency; Italy: The Italian Medicines Agency; Netherlands: Medical Ethics Review Committee (METC); Spain: Spanish Agency of Medicines; Belgium: Federal Agency for Medicinal Products and Health Products; Switzerland: Swissmedic; Austria: Federal Ministry for Health Family and Youth; Denmark: Danish Medicines Agency; Israel: Ministry of Health; Serbia: Agency for Drugs and Medicincal Devices of Serbia |
|
Multiple Sclerosis |
|
Anti-Infective Agents Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Interferons Adjuvants, Immunologic Interferon-beta |
Sclerosis Antiviral Agents Multiple Sclerosis, Relapsing-Remitting Pharmacologic Actions Multiple Sclerosis Pathologic Processes Therapeutic Uses Alemtuzumab Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |