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| Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on February 02, 2012 |
| Title of trial/grant title | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One |
| Current status of trial | Completed |
| Sponsors and collaborators | Genzyme 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(s) | Multiple Sclerosis, Relapsing-Remitting |
| Intervention(s) | 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 | 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 |
| Further study details | 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, patients who receive alemtuzumab may be followed in CAMMS03409 (NCT 00930553) an extension study for safety and efficacy assessments. Patients who receive Rebif® and complete 2 years on study may be eligible to receive alemtuzumab on the 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 Expanded Disability Status Scale (EDSS) 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 magnetic resonance imaging (MRI)-T2 hyperintense lesion volume at Year 2 2 years No |
| Study start | September 2007 |
| Minimum age | 18 Years |
| Maximum age | 50 Years |
| Gender | Both |
| Eligibility criteria | Inclusion Criteria: - Diagnosis of MS and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years - Onset of MS symptoms within 5 years - EDSS score 0.0 to 3.0 - â¿¥2 MS attacks within 24 months, with â¿¥1 attack within 12 months Exclusion Criteria: - Received prior therapy for MS other than corticosteroids - Exposure to immunosuppressive or immunomodulatory agents other than systemic corticosteroid treatment - Received treatment with a monoclonal antibody for any reason - Previous treatment with any investigational drug (i.e. medication that is not approved at any dose for any indication) - Has 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 - 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 |
| 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 Mayo Clinic Arizona Scottsdale Arizona Arizona, United States Northwest NeuroSpecialists, PLLC Tucson Arizona Colorado, United States Advanced Neurosciences Research LLC Fort Collins Colorado Florida, United States Neurological Associates Pompano Beach Florida Florida, United States Axiom Clinical Research of Florida Tampa Florida Idaho, United States Eastern Idaho Neurological Associates Idaho Falls Idaho Illinois, United States Consultants in Neurology, Ltd. Northbrook Illinois Indiana, United States Fort Wayne Neurological Center Fort Wayne Indiana 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 Louisiana, United States Louisiana State University Health Sciences Center Shreveport Louisiana 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 New Hampshire, United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire New York, United States Empire Neurology PC Latham New York New York, United States NYU Hospital of Joint Diseases 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 North Carolina, United States Carolinas Medical Center (CMC)/Neurosciences & Spine Institute (NSSI) Charlotte North Carolina 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 Oklahoma City Oklahoma Pennsylvania, United States Lehigh Valley Hospital, Neuroscience and Pain Research Allentown Pennsylvania Tennessee, United States Advanced Neurosciences Institute Franklin Tennessee Tennessee, United States Sibyl Wray, MD, Neurology, PC Knoxville Tennessee Texas, United States Baylor College of Medicine, Maxine Mesinger MS Clinic Houston Texas Texas, United States Central Texas Neurology Consultants Round Rock Texas Texas, United States Integra Clinical Research, L.L.C. San Antonio Texas Texas, United States Neurology Center of San Antonio San Antonio Texas Argentina DIABAID Capital Federal Queensland, Australia The Wesley Research Institute Auchenflower Queensland 4066 Queensland, Australia Griffith University and Gold Coast Hospital Southport Queensland South Australia, Australia Flinders Medical Center Bedford Park South Australia South Australia, Australia The Queen Elizabeth Hospital Woodville South South Australia Tasmania, Australia Royal Hobart Hospital, Tasmania Hobart Tasmania 7000 Victoria, Australia St Vincents Hospital Fitzroy Victoria 3065 Victoria, Australia Austin Health Heidelberg Victoria 3084 Victoria, Australia Royal Melbourne Hospital, Department of Neurology, Ward 4 East Parkville Victoria 3050 Australia Concord Repatriation General Hospital Concord Australia Southern Neurology Kogarah RS, Brazil Hospital Sao Lucas da PUC-RS Porto Alegre RS SP, Brazil Hospital das Clinicas da Faculdade de Medicina da USP Sao Paulo SP Alberta, Canada Foothills Medical Center, MS Clinic, SSB Calgary Alberta British Columbia, Canada UBC Hospital Vancouver British Columbia Ontario, Canada The Ottawa Hospital, General Campus Ottawa Ontario Quebec, Canada Clinique Nuero-outaouais Gatineau Quebec Quebec, Canada Clinique Nuero rive-sud, Recherche sepmus inc. Greenfield park Quebec Croatia Clinical Hospital Centre "Rijeka" Rijeka Croatia General Hospital Varazdin Varazdin Croatia General Hospital Sveti Duh Zagreb Croatia Clinic of Neurology Clinical Hospital "Sestre milosrdnice" Zagreb Croatia Clinic Hospital Centre Zareb Czech Republic General University Hospital in Prague Prague Czech Republic Hospital Teplice Teplice France Hopital Purpan Toulouse Germany Judisches Krankenhaus Berlin Berlin-Mitte Germany Hospital Neurologique et neuro-chirurgical Pierre Wertheimer Bron Cedex Germany MS Zentrum Dresden Germany Neurologische Klinik Heinrich-Heine-Universitat Dusseldorf Dusseldorf Germany Klinkum der JW Goethe Universitat Frankfurt am Main Germany Medizinische Hochshule Hannover Hannover Germany Klinik Henningsdorf Henningsdorf Tlalpan, Mexico Hospital Medica Sur Delegacion Tlalpan Mexico Hospital Angeles del Pedregal; Camino a Santa Teresa No. 1055 Mexico City Poland Centrum Neurologii Klinicznej Krakow 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 Moscow City Hospital #11 Moscow Russian Federation Russian State Medical University Moscow Russian Federation Municipal City Hospital #33 Nizhniy Novgorod Russian Federation Siberian District Medical Center Novosibirsk Russian Federation City Clinical Hospital #2 Pyatigorsk Russian Federation Samara Regional Clinical Hospital n.a. Kalinin Samara Russian Federation Nikolaevskaya Hospital St. Petersburg Russian Federation St. Petersburg Pavlov State Medical University St. Petersburg Russian Federation Institute of Human Brain RAS St. Petersburg Russian Federation Republican Clinical Hospital Ufa Serbia Clinical Centre Srbija, Institute of Neurology Belgrade Serbia Military Medical Academy Belgrade Serbia Clinical centre Kragujeva Kragujevac Serbia Clinical Center Nis. Center for Neurology Nis Serbia Clinical Centre Vjovodina Institute of Neurology Novi Sad Sweden SU/Ostra sjukhuset MS Centrum Gotenborg Ukraine Institute of Neurology, Psychiatry and Narcology under the Academy of Sciences of Ukraine Department of Neuroinfection and Multiple Sclerosis Kharkov Ukraine Kiev Municipal Clinical Hospital #4 Kiev Ukraine Hospoital of the Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Department Kyiv Ukraine Danylo Halytsky Lviv National Medical University Lviv England, United Kingdom Addenbrooke's Hospital Cambridge England England, United Kingdom The Royal London Hospital London England Wales, United Kingdom University Hospital of Wales, Clinical Research Facility Cardiff Wales United Kingdom Royal Hallamshire Hospital Sheffield |
| Publications | 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. 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. |
| Study ID numbers | CAMMS323; ISRCTN21534255; ACTRN12608000435381; CARE-MS I |
| Last updated | May 25, 2011 |
| Record first received | September 13, 2007 |
| ClinicalTrials.gov identifier | NCT00530348 |
| Download date | Information obtained from ClinicalTrials.gov on February 02, 2012 |
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