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| Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on August 30, 2010 |
| Title of trial/grant title | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two |
| Current status of trial | Active, not recruiting |
| Sponsors and collaborators | Genzyme 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 magnetic resonance imaging (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 | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment |
| 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 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 the CAMMS03409 Extension Study (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. |
| 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 (Expanded Disability Status Scale) 2 years No Acquisition of disability as measured by change from baseline in Multiple Sclerosis Functional Composite (MSFC) 2 years No Percent change from baseline in MRI-T2 hyperintense lesion volume at Year 2 2 years No |
| Study start | October 2007 |
| 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 (NCT00530348) - 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) |
| Study chairs or principal investigators | Medical Monitor, Study Director, Genzyme Coorporation |
| Locations | Alabama, United States North Central Neurology Associates, P.C. Cullman Alabama Arizona, United States Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center Phoenix Arizona Arizona, United States Hope Research Institute Phoenix Arizona Arizona, United States Mayo Clinic Arizona, Department of Neurology Scottsdale Arizona Arizona, United States Northwest NeuroSpecialists, PLLC Tucson Arizona California, United States East Bay Physicians Medical Group/Sutter East Bay Medical Foundation Berkeley California California, United States Neurology Center of North Orange County La Habra California California, United States Department of Neurology, Keck School of Medicine, University of Southern California Los Angeles California California, United States Neuro-Therapeutics, Inc Pasadena California California, United States UC Davis Medical Center Sacramento California California, United States Stanford University Medical Center Stanford California Colorado, United States University of Colorado Hospital Anschutz Outpatient Pavilioin Aurora Colorado Colorado, United States Colorado Neurological Consultants Denver Colorado Colorado, United States Advanced Neurosciences Research LLC Fort Collins Colorado Connecticut, United States Yale University Multiple Sclerosis Center New Haven Connecticut District of Columbia, United States George Washington University Medical Faculty Associates Washington District of Columbia Florida, United States University of Florida Neuroscience Institute Jacksonville Florida Florida, United States Neurology Associates, P.A. Maitland Florida Florida, United States Neurological Associates Pompano Beach Florida Florida, United States Negroski, Stein, Sutherland and Hanes Neurology Sarasota Florida Florida, United States Axiom Clinical Research of Florida Tampa Florida Florida, United States University of South Florida Medical Clinics Tampa Florida Georgia, United States Shephard Center Inc Atlanta Georgia Georgia, United States The Emory Clinic Atlanta Georgia Idaho, United States Eastern Idaho Neurological Associates Idaho Falls Idaho Illinois, United States University of Chicago Medical Center Chicago Illinois Illinois, United States Consultants in Neurology, Ltd Northbrook Illinois Indiana, United States Fort Wayne Neurological Center Fort Wayne Indiana Indiana, United States Indiana University Hospital Indianapolis Indiana Iowa, United States Ruan Neurology Clinic and Research Center Des Moines Iowa Iowa, United States Iowa Health Physicians Des Moines Iowa Kansas, United States University of Kansas Medical Center Kansas City Kansas Kansas, United States MidAmerica Neuroscience Institute Lenexa Kansas Kentucky, United States Associates in Neurology, PSC Lexington Kentucky Kentucky, United States University of Louisville, Kentucky Neuroscience Research Louisville Kentucky Massachusetts, United States Caritas St. Elizabeth's Hospital Medical Center Boston Massachusetts Massachusetts, United States Springfield Neurology Associates, LLC Springfield Massachusetts Massachusetts, United States UMass Memorial Health Care Worcester Massachusetts Michigan, United States University of Michigan Department of Neurology Ann Arbor Michigan Michigan, United States Wayne State University Detroit Michigan Michigan, United States Henry Ford Hospital Detroit Michigan Michigan, United States Michigan Medical, PC Grand Rapids Michigan Michigan, United States Michigan Neurology Associates, P.C. St. Clair Shores Michigan Michigan, United States North Michigan Neurology Traverse City Michigan Mississippi, United States Tupelo Neurology Clinic, PA Tupelo Mississippi Missouri, United States Saint Luke's Hospital Kansas City Missouri Missouri, United States Minor Procedures Center St. Louis Missouri Montana, United States Montana Neurobehavioral Specialists Missoula Montana Nevada, United States Neurology Physicians Reno Nevada New Hampshire, United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire New Jersey, United States MS Center at Holy Name Hospital Teaneck New Jersey New Mexico, United States University of New Mexico Hospital Albuquerque New Mexico New York, United States Empire Neurology PC Latham New York New York, United States Winthrop University Hospital Mineola New York New York, United States NYU Hospital of Joint Diseases New York New York New York, United States Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis New York New York New York, United States Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C. Patchogue New York New York, United States University of Rochester Medical Center Rochester New York New York, United States SUNY Upstate Medical University Syracuse New York North Carolina, United States University of North Caroline-Chapel Hill, Department of Neurology Chapel Hill North Carolina North Carolina, United States Wake Forest University Health Science Winston-Salem North Carolina Ohio, United States The Cleveland Clinic Mellen Center Cleveland Ohio Ohio, United States The Ohio State University Medical Center, Multiple Sclerosis Center Columbus Ohio Ohio, United States Oak Clinic for Multiple Sclerosis Uniontown Ohio Oklahoma, United States MS Center of Oklahoma, Mercy Health Center Oklahoma City Oklahoma Pennsylvania, United States Lehigh Valley Hospital, Neuroscience and Pain Research Allentown Pennsylvania Pennsylvania, United States North Shore Clinical Associates Erie Pennsylvania Pennsylvania, United States University of Pittsburg Pittsburg Pennsylvania Pennsylvania, United States Kaufmann Medical Building, Department of Neurology Pittsburgh Pennsylvania Rhode Island, United States Rhode Island Hospital and The Neurology Foundation, Inc Providence Rhode Island Tennessee, United States Neurology Clinic, P.C. Cordova Tennessee Tennessee, United States Sibyl Wray, MD Neurology, PC Knoxville Tennessee Tennessee, United States Advanced Neurosciences Institute Nashville Tennessee Tennessee, United States Vanderbilt University Medical Center Nashville Tennessee Texas, United States University of Texas Southwestern Medical Center at Dallas Dallas Texas Texas, United States Central Texas Neurology Consultants Round Rock Texas Texas, United States Neurology Center of San Antonio San Antonio Texas Texas, United States Integra Clinical Research San Antonio Texas Virginia, United States MS Center of Greater Washington Vienna Virginia Washington, United States Swedish Neuroscience Institute Seattle Washington Washington, United States Virginia Mason Medical Center Seattle Washington Capital Federal- Buenos Aires, Argentina Diabaid Paraguay Capital Federal- Buenos Aires Queensland, Australia The Wesley Research Institute Auchenflower Queensland 4066 Queensland, Australia Griffith University and Gold Coast Hospital Southport Queensland South Australia, Australia The Queen Elizabeth Hospital Woodville South South Australia Tasmania, Australia Royal Hobart Hospital Hobart Tasmania 7000 Victoria, Australia Royal Melbourne Hospital Parkville Victoria 3050 Australia Concord Repatriation General Hospital Concord Australia Southern Neurology Kogarah Australia Liverpool Hospital Liverpool 2170 Australia St. Vincent's Hospital Melbourne Australia Austin Health Victoria Australia Westmead Hospital Westmead Austria Universitatsklinik fur Neurologie Gurtel Belgium UCL Saint Luc Brussels Belgium CHU Ourthe Ambleve Esneux Belgium UZ Leuven Gasthuisberg Leuven PE, Brazil Hospital da Restauracai Recife PE RS, Brazil Hospital Sao Lucas da PUC-RS Porto Alegre RS Sao Paulo, Brazil Irmandade da Santa Casa de Misericordia de Sao Paulo Vila Buarque Sao Paulo Brazil Hospital das Clinicas da Faculdade de Medicina da USP Sao Paulo British Columbia, Canada UBC Hospital 2211 Westbrook Mall Vancouver British Columbia Ontario, Canada Multiple Sclerosis Clinic, Kingston General Hospital Kingston Ontario Ontario, Canada London Health Sciences Centre- University Hospital London Ontario Ontario, Canada Ottawa Hospital-General Campus Ottawa Ontario Quebec, Canada Clinique de neurologie de l'Outaouais Gatineau Quebec Quebec, Canada Clinique Neuro rive-sud, Recherche sepmus inc Greenfield park Quebec Quebec, Canada Hospital Maisonneuve-Rosemont Montreal Quebec 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 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 Denmark Aarhus Sygehus Aarhus Denmark Righospitalet Copenhagen Denmark Odense University Hospital Odense Cedex, France Hopital Civil Strasbourg Cedex France Hopital Neurologique Bron Cedex France Group Hospitalier Pitie Salpetriere Cedex France Hospital General Service de Neurologie Cedex France Hospital Roger Salengro Cedex France CHU Pontchaillou Rennes 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 Israel Haddasah Medical Organisation Jerusalem Israel Souraski TA Medical Centre Tel Aviv Israel Sheba Medical Centre Tel Hashomer 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 Tlalpan, Mexico Hospital Medica Sur Delegacion Tlalpan Mexico Ortiz Mena 2200 Col. Las Palmas Chihuahua Mexico Hospital Angeles del Pedregal; Camino a Santa Teresa Mexico City Netherlands Jeroen Bosch Ziekenhuis Den Bosch Netherlands Faculty of Health Medicine and Life Science Sittard 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 Russian Federation Research Medical Complex "Your Health" Ltd Kazan Russian Federation State Institution Scientific Neurology Center RAMS Moscow Russian Federation Russian State Medical University Moscow Russian Federation Moscow City Hospital #11 Moscow Russian Federation Municipal City Hospital #33 Nizhny Novgorod Russian Federation Siberian District Medical Center Novosibirsk Russian Federation Samara Regional Clinical Hospital n.a. Kalinin Samara 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 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 Spain Hospital Vall d'Hebron Barcelona Spain Hospital Clinico Universtitario San Carlos Madrid Spain Hospital Carlos Haya Malaga Spain Hospital University Virgen Macarena Sevilla Sweden SU/Ostra sjukhuset Forskningsenheten Gothenburg Sweden Norrlands Universitets sjukhus Umea 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 England, United Kingdom Addenbrooke's Hospital, University Neurology unit Cambridge England England, United Kingdom The Royal London Hospital London England United Kingdom Institute of Clinical Neurosciences Frenchay Hospital Bristol United Kingdom Salford Royal Hospital Salford United Kingdom Royal Hallamshire Hospital Sheffield |
| 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,; ISRCTN70702834; ACTRN12608000426381; NTR1469; CARE-MS II |
| Last updated | July 9, 2010 |
| Record first received | October 22, 2007 |
| ClinicalTrials.gov identifier | NCT00548405 |
| Download date | Information obtained from ClinicalTrials.gov on August 30, 2010 |
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