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| Sponsor: | Genzyme |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00530348 |
Purpose
The purpose of this study is to establish the efficacy and safety 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 not previously received treatment to suppress MS, except steroids. 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: | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis |
| Enrollment: | 581 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2011 (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.
|
| interferon beta-1a (Rebif ®) 44mcg: 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 who qualify will be randomly assigned to treatment with either alemtuzumab or Rebif® at a 2:1 ratio (ie, 2 given 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 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 50 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 | |
| Northwest NeuroSpecialists, PLLC | |
| Tucson, Arizona, United States | |
| Mayo Clinic Arizona | |
| Scottsdale, Arizona, United States | |
| United States, Colorado | |
| Advanced Neurosciences Research LLC | |
| Fort Collins, Colorado, United States | |
| United States, Florida | |
| Axiom Clinical Research of Florida | |
| Tampa, Florida, United States | |
| Neurological Associates | |
| Pompano Beach, Florida, United States | |
| United States, Idaho | |
| Eastern Idaho Neurological Associates | |
| Idaho Falls, Idaho, United States | |
| United States, Illinois | |
| Consultants in Neurology, Ltd. | |
| Northbrook, Illinois, United States | |
| United States, Indiana | |
| Fort Wayne Neurological Center | |
| Fort Wayne, Indiana, 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, Louisiana | |
| Louisiana State University Health Sciences Center | |
| Shreveport, Louisiana, United States | |
| United States, Massachusetts | |
| UMass Memorial Health Care | |
| Worcester, Massachusetts, United States | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States | |
| University of Michigan Department of Neurology | |
| Ann Arbor, Michigan, United States | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States | |
| United States, New York | |
| NYU Hospital of Joint Diseases | |
| New York, New York, United States | |
| Empire Neurology PC | |
| Latham, New York, United States | |
| University of Rochester Medical Center | |
| Rochester, New York, United States | |
| Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C. | |
| Patchogue, New York, United States | |
| United States, North Carolina | |
| Carolinas Medical Center (CMC)/Neurosciences & Spine Institute (NSSI) | |
| Charlotte, North Carolina, United States | |
| United States, Ohio | |
| 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 | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital, Neuroscience and Pain Research | |
| Allentown, Pennsylvania, United States | |
| United States, Tennessee | |
| Sibyl Wray, MD, Neurology, PC | |
| Knoxville, Tennessee, United States | |
| Advanced Neurosciences Institute | |
| Franklin, Tennessee, United States | |
| United States, Texas | |
| Integra Clinical Research, L.L.C. | |
| San Antonio, Texas, United States | |
| Central Texas Neurology Consultants | |
| Round Rock, Texas, United States | |
| Neurology Center of San Antonio | |
| San Antonio, Texas, United States | |
| Baylor College of Medicine, Maxine Mesinger MS Clinic | |
| Houston, Texas, United States | |
| Argentina | |
| DIABAID | |
| Capital Federal, Argentina | |
| Australia | |
| Concord Repatriation General Hospital | |
| Concord, Australia | |
| Sir Charles Gairdner Hospital | |
| Nedlands, Australia | |
| Southern Neurology | |
| Kogarah, Australia | |
| Australia, Queensland | |
| Griffith University and Gold Coast Hospital | |
| Southport, Queensland, Australia | |
| The Wesley Research Institute | |
| Auchenflower, Queensland, Australia, 4066 | |
| Australia, South Australia | |
| The Queen Elizabeth Hospital | |
| Woodville South, South Australia, Australia | |
| Flinders Medical Center | |
| Bedford Park, South Australia, Australia | |
| Australia, Tasmania | |
| Royal Hobart Hospital, Tasmania | |
| Hobart, Tasmania, Australia, 7000 | |
| Australia, Victoria | |
| Austin Health | |
| Heidelberg, Victoria, Australia, 3084 | |
| St Vincents Hospital | |
| Fitzroy, Victoria, Australia, 3065 | |
| Royal Melbourne Hospital, Department of Neurology, Ward 4 East | |
| Parkville, Victoria, Australia, 3050 | |
| Brazil, PE | |
| Hospital da Restauracao | |
| Recife, PE, Brazil | |
| Brazil, RS | |
| Hospital Sao Lucas da PUC-RS | |
| Porto Alegre, RS, Brazil | |
| Brazil, SP | |
| Hospital das Clinicas da Faculdade de Medicina da USP | |
| Sao Paulo, SP, Brazil | |
| Canada, Alberta | |
| Foothills Medical Center, MS Clinic, SSB | |
| Calgary, Alberta, Canada | |
| Canada, British Columbia | |
| UBC Hospital | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| The Ottawa Hospital, General Campus | |
| Ottawa, Ontario, Canada | |
| Canada, Quebec | |
| Clinique Nuero rive-sud, Recherche sepmus inc. | |
| Greenfield park, Quebec, Canada | |
| Clinique Nuero-outaouais | |
| Gatineau, Quebec, Canada | |
| Croatia | |
| General Hospital Sveti Duh | |
| Zagreb, Croatia | |
| Clinic Hospital Centre | |
| Zareb, Croatia | |
| General Hospital Varazdin | |
| Varazdin, Croatia | |
| Clinical Hospital Centre "Rijeka" | |
| Rijeka, Croatia | |
| Clinic of Neurology Clinical Hospital "Sestre milosrdnice" | |
| Zagreb, Croatia | |
| Czech Republic | |
| General University Hospital in Prague | |
| Prague, Czech Republic | |
| Hospital Teplice | |
| Teplice, Czech Republic | |
| France | |
| Hopital Purpan | |
| Toulouse, France | |
| Germany | |
| Hospital Neurologique et neuro-chirurgical Pierre Wertheimer | |
| Bron Cedex, Germany | |
| Neurologische Klinik Heinrich-Heine-Universitat Dusseldorf | |
| Dusseldorf, Germany | |
| Judisches Krankenhaus Berlin | |
| Berlin-Mitte, Germany | |
| MS Zentrum | |
| Dresden, Germany | |
| Klinik Henningsdorf | |
| Henningsdorf, Germany | |
| Klinkum der JW Goethe Universitat | |
| Frankfurt am Main, Germany | |
| Medizinische Hochshule Hannover | |
| Hannover, Germany | |
| Mexico | |
| Hospital Angeles del Pedregal; Camino a Santa Teresa No. 1055 | |
| Mexico City, Mexico | |
| Mexico, Tlalpan | |
| Hospital Medica Sur | |
| Delegacion, Tlalpan, Mexico | |
| 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 | |
| Centrum Neurologii Klinicznej | |
| Krakow, Poland | |
| Russian Federation | |
| State Institution Scientific Neurology Center, RAMS | |
| Moscow, Russian Federation | |
| Nikolaevskaya Hospital | |
| St. Petersburg, Russian Federation | |
| Municipal City Hospital #33 | |
| Nizhniy Novgorod, Russian Federation | |
| Moscow City Hospital #11 | |
| Moscow, Russian Federation | |
| Siberian District Medical Center | |
| Novosibirsk, Russian Federation | |
| Institute of Human Brain RAS | |
| St. Petersburg, Russian Federation | |
| St. Petersburg Pavlov State Medical University | |
| St. Petersburg, Russian Federation | |
| City Clinical Hospital #2 | |
| Pyatigorsk, Russian Federation | |
| Research Medical Complex "Your Health" Ltd | |
| Kazan, Russian Federation | |
| Russian State Medical University | |
| Moscow, Russian Federation | |
| Samara Regional Clinical Hospital n.a. Kalinin | |
| Samara, Russian Federation | |
| Republican Clinical Hospital | |
| Ufa, Russian Federation | |
| Serbia | |
| Clinical Centre Srbija, Institute of Neurology | |
| Belgrade, Serbia | |
| Clinical Center Nis. Center for Neurology | |
| Nis, Serbia | |
| Clinical centre Kragujeva | |
| Kragujevac, Serbia | |
| Military Medical Academy | |
| Belgrade, Serbia | |
| Clinical Centre Vjovodina Institute of Neurology | |
| Novi Sad, Serbia | |
| Sweden | |
| SU/Ostra sjukhuset MS Centrum | |
| Gotenborg, Sweden | |
| Ukraine | |
| Kiev Municipal Clinical Hospital #4 | |
| Kiev, Ukraine | |
| Danylo Halytsky Lviv National Medical University | |
| Lviv, Ukraine | |
| Institute of Neurology, Psychiatry and Narcology under the Academy of Sciences of Ukraine Department of Neuroinfection and Multiple Sclerosis | |
| Kharkov, Ukraine | |
| Hospoital of the Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Department | |
| Kyiv, Ukraine | |
| United Kingdom | |
| Royal Hallamshire Hospital | |
| Sheffield, United Kingdom | |
| United Kingdom, England | |
| Addenbrooke's Hospital | |
| Cambridge, England, United Kingdom | |
| The Royal London Hospital | |
| London, England, United Kingdom | |
| United Kingdom, Wales | |
| University Hospital of Wales, Clinical Research Facility | |
| Cardiff, Wales, United Kingdom | |
| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
| Study ID Numbers: | CAMMS323, ISRCTN21534255,, ACTRN12608000435381 |
| Study First Received: | September 13, 2007 |
| Last Updated: | October 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00530348 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; Croatia: Ministry of Health and Social Care; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Ukraine: State Pharmacological Center - Ministry of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Russia: Ministry of Health and Social Development of the Russian Federation; Mexico: Federal Commission for Sanitary Risks Protection; Brazil: National Health Surveillance Agency |
|
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 |