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| [ Print-friendly version ] |
| Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on July 02, 2009 |
| Title of trial/grant title | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two |
| Current status of trial | Recruiting |
| Sponsors and collaborators | Genzyme Bayer Schering Pharmaceutical |
| 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(s) | Multiple Sclerosis, Relapsing-Remitting |
| Intervention(s) | Biological: alemtuzumab Biological: alemtuzumab Biological: interferon beta-1a (Rebif®) |
| Phase | Phase III |
| Study type and 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 |
| Further study details | Every patient will receive active treatment; there is no placebo. The 24 mg alemtuzumab dose is closed to enrollment so newly enrolled patients will be randomly assigned to treatment with either 12 mg alemtuzumab or Rebif® at a 2:1 ratio (ie, 2 given 12 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 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. |
| Primary outcome | Time to Sustained Accumulation of Disability (SAD) 2 years No Relapse Rate 2 years No |
| Secondary outcome | Proportion of patients who are relapse free at Year 2 2 years No Change from baseline in EDSS 2 years No Acquisition of disability as measured by change from baseline in MSFC 2 years No Percent change from baseline in MRI-T2 hyperintense lesion volume at Year 2 2 years No |
| Study start | October 2007 |
| Expected completion | April 2012 |
| Minimum age | 18 Years |
| Maximum age | 55 Years |
| Gender | Both |
| Eligibility criteria | Inclusion Criteria: - Diagnosis of MS and MRI scan demonstrating white matter lesions attributable to MS - Onset of MS symptoms within 10 years - EDSS score 0.0 to 5.0 - â¿¥2 MS attacks within 24 months, with â¿¥1 attack within 12 months - â¿¥1 MS attack (relapse)during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for at least 6 months within 10 years Exclusion Criteria: - Previous treatment with alemtuzumab - Previous treatment with any investigational drug (i.e. a medication that is not approved at any dose or for any indication) - Treatment with natalizumab, methotrexate, azothioprine or cyclosporine in the past 6 months - Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, or any other immunosuppressive, or cytotoxic therapy (other than steroid treatment) - Any progressive form of MS - Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS - Major systemic disease that cannot be treated or adequately controlled by therapy - Active infection or high risk for infection - Autoimmune disorder (other than MS) - Impaired hepatic or renal function - History of malignancy, except basal skin cell carcinoma - Medical, psychiatric, cognitive, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study - Known bleeding disorder - Of childbearing potential with a positive serum pregnancy test, pregnant, or lactating - Current participation in another clinical study or previous participation in CAMMS323 - Previous hypersensitivity reaction to any immunoglobulin product - Known allergy or intolerance to interferon beta, human albumin, or mannitol - Intolerance of pulsed corticosteroids, especially a history of steroid psychosis - Inability to self-administer subcutaneous (SC) injections or receive SC injections from caregiver - Inability to undergo MRI with gadolinium administration - Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only) |
| Overall contact | Primary: CARE-MS Call Center, http://www.care-ms.com/ tel: 888-417-MS-CARE ext.: (Toll-Free US |
| Study chairs or principal investigators | Medical Monitor, Study Director, Genzyme Coorporation |
| Backup contact | Secondary: Genzyme Medical Information, 800-745-4447 (option 2) tel: or: 617-768-9000 medinfo@genzyme.com |
| Locations | Alabama, United States North Central Neurology Associates, P.C. Cullman Alabama Status: Recruiting Arizona, United States Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center Phoenix Arizona Status: Recruiting Arizona, United States Northwest NeuroSpecialists, PLLC Tucson Arizona Status: Recruiting Arizona, United States Mayo Clinic Arizona, Department of Neurology Scottsdale Arizona Status: Recruiting Arizona, United States Hope Research Institute Phoenix Arizona Status: Recruiting Arizona, United States Phoenix Neurological Associates LTD Phoenix Arizona Status: Recruiting California, United States East Bay Physicians Medical Group/Sutter East Bay Medical Foundation Berkeley California Status: Recruiting California, United States UC Davis Medical Center Sacramento California Status: Recruiting California, United States Department of Neurology, Keck School of Medicine, University of Southern California Los Angeles California Status: Recruiting California, United States Neurology Center of North Orange County La Habra California Status: Recruiting California, United States Tower Hematology Oncology Medical Group Beverly Hills California Status: Recruiting California, United States Stanford University Medical Center Stanford California Status: Recruiting Colorado, United States Advanced Neurosciences Research LLC Fort Collins Colorado Status: Recruiting Colorado, United States Colorado Neurological Consultants Denver Colorado Status: Recruiting Colorado, United States University of Colorado Hospital Anschutz Outpatient Pavilioin Aurora Colorado Status: Recruiting Connecticut, United States Yale University Multiple Sclerosis Center New Haven Connecticut Status: Recruiting District of Columbia, United States George Washington University Medical Faculty Associates Washington District of Columbia Status: Recruiting Florida, United States Axiom Clinical Research of Florida Tampa Florida Status: Recruiting Florida, United States Neurological Associates Pompano Beach Florida Status: Recruiting Florida, United States University of South Florida Medical Clinics Tampa Florida Status: Recruiting Florida, United States Neurology Associates, P.A. Maitland Florida Status: Recruiting Florida, United States University of Florida Neuroscience Institute Jacksonville Florida Status: Recruiting Florida, United States Negroski, Stein, Sutherland and Hanes Neurology Sarasota Florida Status: Recruiting Georgia, United States Shephard Center Inc Atlanta Georgia Status: Recruiting Georgia, United States The Emory Clinic Atlanta Georgia Status: Recruiting Idaho, United States Eastern Idaho Neurological Associates Idaho Falls Idaho Status: Recruiting Illinois, United States Consultants in Neurology, Ltd Northbrook Illinois Status: Recruiting Illinois, United States University of Chicago Medical Center Chicago Illinois Status: Recruiting Illinois, United States OSF Saint Francis Medical Center Peoria Illinois Status: Recruiting Indiana, United States Fort Wayne Neurological Center Fort Wayne Indiana Status: Recruiting Indiana, United States Indiana University Hospital Indianapolis Indiana Status: Recruiting Iowa, United States Ruan Neurology Clinic and Research Center Des Moines Iowa Status: Recruiting Iowa, United States Iowa Health Physicians Des Moines Iowa Status: Recruiting Kansas, United States University of Kansas Medical Center Kansas City Kansas Status: Recruiting Kansas, United States MidAmerica Neuroscience Institute Lenexa Kansas Status: Recruiting Kentucky, United States Associates in Neurology, PSC Lexington Kentucky Status: Recruiting Kentucky, United States University of Louisville, Kentucky Neuroscience Research Louisville Kentucky Status: Recruiting Louisiana, United States Louisiana State University Health Sciences Center Shreveport Louisiana Status: Recruiting Massachusetts, United States UMass Memorial Health Care Worcester Massachusetts Status: Recruiting Massachusetts, United States Caritas St. Elizabeth's Hospital Medical Center Boston Massachusetts Status: Recruiting Massachusetts, United States Springfield Neurology Associates, LLC Springfield Massachusetts Status: Recruiting Michigan, United States Michigan Medical, PC Grand Rapids Michigan Status: Recruiting Michigan, United States The Henry Ford Hospital Detroit Michigan Status: Recruiting Michigan, United States Wayne State University Detroit Michigan Status: Recruiting Michigan, United States Michigan Neurology Associates, P.C. St. Clair Shores Michigan Status: Recruiting Michigan, United States University of Michigan Department of Neurology Ann Arbor Michigan Status: Recruiting Michigan, United States North Michigan Neurology Traverse City Michigan Status: Recruiting Mississippi, United States Tupelo Neurology Clinic, PA Tupelo Mississippi Status: Recruiting Missouri, United States Minor Procedures Center St. Louis Missouri Status: Recruiting Missouri, United States Saint Luke's Hospital Kansas City Missouri Status: Recruiting Missouri, United States Washington University School of Medicine St. Louis Missouri Status: Recruiting Montana, United States Montana Neurobehavioral Specialists Missoula Montana Status: Recruiting Nevada, United States Neurology Physicians Reno Nevada Status: Recruiting New Hampshire, United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire Status: Recruiting New Jersey, United States MS Center at Holy Name Hospital Teaneck New Jersey Status: Recruiting New Mexico, United States University of New Mexico Hospital Albuquerque New Mexico Status: Recruiting New York, United States NYU Hospital of Joint Diseases New York New York Status: Recruiting New York, United States Empire Neurology PC Latham New York Status: Recruiting New York, United States Winthrop University Hospital Mineola New York Status: Recruiting New York, United States University of Rochester Medical Center Rochester New York Status: Recruiting New York, United States Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis New York New York Status: Recruiting New York, United States Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C. Patchogue New York Status: Recruiting New York, United States SUNY Upstate Medical University Syracuse New York Status: Recruiting North Carolina, United States Wake Forest University Health Science Winston-Salem North Carolina Status: Recruiting North Carolina, United States University of North Caroline-Chapel Hill, Department of Neurology Chapel Hill North Carolina Status: Recruiting Ohio, United States The Ohio State University Medical Center, Multiple Sclerosis Center Columbus Ohio Status: Recruiting Ohio, United States The Cleveland Clinic Mellen Center Cleveland Ohio Status: Recruiting Ohio, United States Oak Clinic for Multiple Sclerosis Uniontown Ohio Status: Recruiting Oklahoma, United States MS Center of Oklahoma, Mercy Health Center Oklahoma City Oklahoma Status: Recruiting Pennsylvania, United States Kaufmann Medical Building, Department of Neurology Pittsburgh Pennsylvania Status: Recruiting Pennsylvania, United States North Shore Clinical Associates Erie Pennsylvania Status: Recruiting Pennsylvania, United States Lehigh Valley Hospital, Neuroscience and Pain Research Allentown Pennsylvania Status: Recruiting Rhode Island, United States Rhode Island Hospital and The Neurology Foundation, Inc Providence Rhode Island Status: Recruiting Tennessee, United States Sibyl Wray, MD Neurology, PC Knoxville Tennessee Status: Recruiting Tennessee, United States Advanced Neurosciences Institute Nashville Tennessee Status: Recruiting Tennessee, United States Vanderbilt University Medical Center Nashville Tennessee Status: Recruiting Tennessee, United States Neurology Clinic, P.C. Cordova Tennessee Status: Recruiting Texas, United States Integra Clinical Research, L.L.C. San Antonio Texas Status: Recruiting Texas, United States Neurology Center of San Antonio San Antonio Texas Status: Recruiting Texas, United States Central Texas Neurology Consultants Round Rock Texas Status: Recruiting Virginia, United States MS Center of Greater Washington Vienna Virginia Status: Recruiting Washington, United States Swedish Neuroscience Institute Seattle Washington Status: Recruiting Washington, United States Virginia Mason Medical Center Seattle Washington Status: Recruiting Capital Federal- Buenos Aires, Argentina DIABAID Paraguay Capital Federal- Buenos Aires Status: Recruiting Australia St. Vincent's Hospital Melbourne Status: Recruiting Australia Austin Health Victoria Status: Recruiting Australia Southern Neurology Kogarah Status: Recruiting Australia Westmead Hospital Westmead Status: Recruiting Australia Concord Repatriation General Hospital Concord Status: Recruiting Australia Liverpool Hospital Liverpool 2170 Status: Recruiting Queensland, Australia Griffith University and Gold Coast Hospital Southport Queensland Status: Recruiting Queensland, Australia The Wesley Research Institute Auchenflower Queensland 4066 Status: Recruiting South Australia, Australia The Queen Elizabeth Hospital Woodville South South Australia Status: Recruiting Tasmania, Australia Royal Hobart Hospital Hobart Tasmania 7000 Status: Recruiting Victoria, Australia Royal Melbourne Hospital Parkville Victoria 3050 Status: Recruiting Belgium UZ Leuven Gasthuisberg Leuven Status: Recruiting Belgium CHU Ourthe Ambleve Esneux Status: Recruiting Belgium UCL Saint Luc Brussels Status: Recruiting Brazil Hospital das Clinicas da Faculdade de Medicina da USP Sao Paulo Status: Recruiting PE, Brazil Hospital da Restauracai Recife PE Status: Recruiting RS, Brazil Hospital Sao Lucas da PUC-RS Porto Alegre RS Status: Recruiting Sao Paulo, Brazil Irmandade da Santa Casa de Misericordia de Sao Paulo Vila Buarque Sao Paulo Status: Recruiting British Columbia, Canada UBC Hospital 2211 Westbrook Mall Vancouver British Columbia Status: Recruiting Ontario, Canada Multiple Sclerosis Clinic, Kingston General Hospital Kingston Ontario Status: Recruiting Ontario, Canada Ottawa Hospital-General Campus Ottawa Ontario Status: Recruiting Ontario, Canada London Health Sciences Centre- University Hospital London Ontario Status: Recruiting Quebec, Canada Clinique de neurologie de l'Outaouais Gatineau Quebec Status: Recruiting Quebec, Canada Clinique Neuro rive-sud, Recherche sepmus inc Greenfield park Quebec Status: Recruiting Quebec, Canada Hospital Maisonneuve-Rosemont Montreal Quebec Status: Recruiting Croatia General Hospital Varazdin Varazdin Status: Recruiting Croatia Clinical Hospital Centre Rijeka Rijeka Status: Recruiting Croatia Clinical Hospital Centre Zagreb Zagreb Status: Recruiting Croatia Clinical Hospital Sveti Duh Zagreb Status: Recruiting Croatia Clinical Hospital Sestre Milosrdnice Zagreb Status: Recruiting Czech Republic Hospital Teplice Teplice Status: Recruiting Czech Republic St. Anne's University Hospital Brno Pekarska Status: Recruiting Czech Republic General University Hospital in Prague Prague Status: Recruiting Czech Republic University Hospital Hradec, Kralove Hradec Kralove Status: Recruiting Denmark Aarhus Sygehus Aarhus Status: Recruiting Denmark Righospitalet Copenhagen Status: Recruiting Denmark Odense University Hospital Odense Status: Recruiting France Hopital Gabriel Montpied Cedex Status: Recruiting France Hopital Neurologique Bron Cedex Status: Recruiting France CHU Pontchaillou Rennes Status: Recruiting France Hospital General Service de Neurologie Cedex Status: Recruiting France Hospital Roger Salengro Cedex Status: Recruiting France Group Hospitalier Pitie Salpetriere Cedex Status: Recruiting Cedex, France Hopital Civil Strasbourg Cedex Status: Recruiting Germany Krankenhaus Henningsdorf Abteilung fur Neurologie Henningsdorf Status: Recruiting Germany Neurologische Universitasklink Dresden Status: Recruiting Germany Medizinische Hochshule Hannover Hannover Status: Recruiting Germany Neurologiche Klinik und Poliklinik der TU Muenchen Muenchen Status: Recruiting Germany Klinik fur Neurologie Universitatsklinikum Bon Bonn Status: Recruiting Germany Neurologische Klinik Dusseldorf Status: Recruiting Germany Klinik und Poliklinik fur Neurologie der Universitat Rockstock Rockstock Status: Recruiting Germany Universitatsklinik Ulm Ulm Status: Recruiting Germany Judisches Krankenhaus Berlin Berlin-Mitte Status: Recruiting Germany Universitat Leipzig Leipzig Status: Recruiting Germany Fachkrankenhaus Hubertusburg GmbH Wemsdorf Status: Recruiting Israel Sheba Medical Centre Tel Hashomer Status: Recruiting Israel Haddasah Medical Organisation Jerusalem Status: Recruiting Israel Souraski TA Medical Centre Tel Aviv Status: Recruiting Italy IRCCS San Raffaele Hospital Milan Status: Recruiting Italy Azienda Ospidaliera S. Antonio Abate di Gallarate Gallarate Status: Recruiting Italy A.O.U.S. Luigi Gonzaga di Orbassano Orbassano Status: Recruiting Italy Ospedale San Luigi Gonzaga Orbassano Status: Recruiting Italy Azienda Ospidaliera S. Antonio Abate di Gallarate Rome Status: Recruiting Italy Spedali Civili Presidio di Montichiari Montichiari Status: Recruiting Mexico Hospital Angeles del Pedregal; Camino a Santa Teresa Mexico City Status: Recruiting Mexico Ortiz Mena 2200 Col. Las Palmas Chihuahua Status: Recruiting Tlalpan, Mexico Hospital Medica Sur Delegacion Tlalpan Status: Recruiting Netherlands Faculty of Health Medicine and Life Science Sittard Status: Recruiting Netherlands Jeroen Bosch Ziekenhuis Den Bosch Status: Recruiting Poland Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny nr 1 UM w Lodzi Lodz Status: Recruiting Poland Samodzielny Publiczny Szpital Kliniczny nr 4 Lublin Status: Recruiting Poland Szpital Kliniczny im. Helidora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Poznan Status: Recruiting Russian Federation State Institution Scientific Neurology Center RAMS Moscow Status: Recruiting Russian Federation Russian State Medical University Moscow Status: Recruiting Russian Federation Moscow City Hospital #11 Moscow Status: Recruiting Russian Federation Nikolaevskaya Hospital St. Petersburg Status: Recruiting Russian Federation Siberian District Medical Center Novosibirsk Status: Recruiting Russian Federation Research Medical Complex "Your Health" Ltd Kazan Status: Recruiting Russian Federation St. Petersburg General Hospital No.2 St. Petersburg Status: Recruiting Russian Federation Municipal City Hospital #33 Nizhny Novgorod Status: Recruiting Russian Federation St. Petersburg Pavlov State Medical University St. Petersburg Status: Recruiting Russian Federation Samara Regional Clinical Hospital n.a. Kalinin Samara Status: Recruiting Russian Federation Insitute of Human Brain RAS St. Petersburg Status: Recruiting Serbia Clinical Centre of Serbia Belgrade Status: Recruiting Serbia Clinical Centre of Kragujevac Kragujevac Status: Recruiting Serbia Military Medical Academy Belgrade Status: Recruiting Serbia Clinical Centre Vjovodina Institute of Neurology Novi Sad Status: Recruiting Spain Hospital University Virgen Macarena Sevilla Status: Recruiting Spain Hospital Vall d'Hebron Barcelona Status: Recruiting Spain Hospital Clinico Universtitario San Carlos Madrid Status: Recruiting Spain Hospital Carlos Haya Malaga Status: Recruiting Sweden SU/Ostra sjukhuset Forskningsenheten Gothenburg Status: Recruiting Sweden Norrlands Universitets sjukhus Umea Status: Recruiting Ukraine Kiev Municipal Clinical Hospital #4 Kiev Status: Recruiting Ukraine Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine Kharkov Status: Recruiting Ukraine Danylo Halytsky National Medical University Lviv Status: Recruiting United Kingdom Institute of Clinical Neurosciences Frenchay Hospital Bristol Status: Recruiting United Kingdom Royal Hallamshire Hospital Sheffield Status: Recruiting United Kingdom Salford Royal Hospital Salford Status: Recruiting England, United Kingdom Addenbrooke's Hospital, University Neurology unit Cambridge England Status: Recruiting England, United Kingdom The Royal London Hospital London England Status: Recruiting England, United Kingdom The Walton Centre for Neurology Liverpool England Status: Recruiting |
| Links | US FDA Approved Full Prescribing Information for alemtuzumab (Campath®) |
| Publications | Fox E, Sullivan H, Gazda S. Open label, single-arm, Phase II study of alemtuzumab in patients with active relapsing-remitting multiple sclerosis who have failed licensed beta-interferon therapies. Poster presentation P06.07 at the 59th Annual Meeting of the American Academy of Neurology (AAN) on 03 May 2007. CAMMS223 Trial Investigators; Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK. Alemtuzumab vs. Interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008 Oct 23;359(17):1786-801. Coles AJ, Cox A, Le Page E, Jones J, Trip SA, Deans J, Seaman S, Miller DH, Hale G, Waldmann H, Compston DA. The window of therapeutic opportunity in multiple sclerosis: evidence from monoclonal antibody therapy. J Neurol. 2006 Jan;253(1):98-108. Epub 2005 Jul 27. |
| Study ID numbers | CAMMS32400507; CAMMS324 |
| Last updated | June 24, 2009 |
| Record first received | October 22, 2007 |
| ClinicalTrials.gov identifier | NCT00548405 |
| Download date | Information obtained from ClinicalTrials.gov on July 02, 2009 |
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| terms & conditions | privacy statement | © Current Controlled Trials Ltd. Part of Springer Science+Business Media. | |
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