Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One
NCT ID: NCT00530348
Last Updated: 2014-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
581 participants
INTERVENTIONAL
2007-08-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Alemtuzumab
Alemtuzumab
Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
Interferon Beta-1a
Interferon beta-1a
Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Interventions
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Alemtuzumab
Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
Interferon beta-1a
Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 to 50 years old (inclusive) as of the date the informed consent form (ICF) was signed
* Diagnosis of MS per updated McDonald criteria, and cranial magnetic resonance imaging (MRI) scan demonstrating white matter lesions attributable to MS within 5 years of screening
* Onset of MS symptoms (as determined by a neurologist, either at screening or retrospectively) within 5 years of the date the ICF was signed
* Expanded Disability Status Scale (EDSS) score 0.0 to 3.0 (inclusive) at screening
* Greater than or equal to (\>=) 2 MS attacks (first episode or relapse) occurring in the 24 months prior to the date the ICF was signed, with \>=1 attack in the 12 months prior to the date the ICF was signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other Genzyme-approved health-care provider and the objective signs could be identified retrospectively
Exclusion Criteria
* Exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, or any other immunosuppressive agent other than systemic corticosteroid treatment
* Any progressive form of MS
* History of malignancy (except basal skin cell carcinoma)
* CD4 + , CD8 + count, B cell, or absolute neutrophil count less than (\<) lower limit of normal (LLN) at screening
* Known bleeding disorder (for example, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, or clotting factor deficiency)
* Significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
* Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (that is, above the LLN)
* Active infection or at high risk for infection
18 Years
50 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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North Central Neurology Associates, P.C.
Cullman, Alabama, United States
Barrow Neurological Institute, St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, United States
Advanced Neurosciences Research
Fort Collins, Colorado, United States
Neurological Associates
Pompano Beach, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Idaho Falls Multiple Sclerosis Center, PLLC
Idaho Falls, Idaho, United States
Consultants in Neurology, Ltd.
Northbrook, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
MidAmerican Neuroscience Institute
Lenexa, Kansas, United States
Associates in Neurology, PSC
Lexington, Kentucky, United States
University of Louisville Research Foundation
Louisville, Kentucky, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
University of New Mexico, Health Sciences Center, MS Specialty Clinic
Albuquerque, New Mexico, United States
Empire Neurology
Latham, 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
Carolinas Medical Center (CMC), Neurosciences & Spine Institute (NSSI)
Charlotte, North Carolina, United States
The Ohio State University Medical Center, Multiple Sclerosis Center
Columbus, Ohio, United States
Oak Clinic for Multiple Sclerosis
Uniontown, Ohio, United States
MS Center of Oklahoma
Oklahoma City, Oklahoma, United States
Lehigh Valley Hospital Neurosciences and Pain Research
Allentown, Pennsylvania, United States
Advanced Neurosciences Institute
Franklin, Tennessee, United States
Biomedical Research Alliance of NY, LLC
Franklin, Tennessee, United States
Hope Neurology PC
Knoxville, Tennessee, United States
Baylor College of Medicine, Maxine Mesinger MS Clinic
Houston, Texas, United States
Central Texas Neurology
Round Rock, Texas, United States
Integra Clinical Research
San Antonio, Texas, United States
Neurology Center of San Antonio
San Antonio, Texas, United States
DIABAID
Buenos Aires, , Argentina
The Wesley Research Institute
Auchenflower, Queensland, Australia
Griffith University School of Medicine
Southport, Queensland, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Royal Melbourne Hospital, Department of Neurology, Ward 4 East
Parkville, Victoria, Australia
Concord Repatriation General Hospital
Concord, , Australia
Westmead Hospital
Westmead, , Australia
Hospital da Restauracao, Av Governador Agamenon Magalhaes
Recife, Pernambuco, Brazil
Hospital Sao Lucas PUC-RS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas USP
São Paulo, São Paulo, Brazil
University of Calgary and Foothills Medical Cenre
Calgary, Alberta, Canada
UBC Hospital
Vancouver, British Columbia, Canada
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Clinique Nuero-outaouais
Gatineau, Quebec, Canada
Clinique Neuro rive-sud, Recherche Sepmus, Inc.
Greenfield Park, Quebec, Canada
Clinical Hospital Centre Rijeka
Rijeka, , Croatia
General Hospital Varazdin
Varaždin, , Croatia
Clinical Hospital Centre "Sestre Milosrdnice"
Zagreb, , Croatia
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
General Hospital "Sveti Duh"
Zagreb, , Croatia
Department of Neurology, 1st Faculty of Medicine and General Teaching Hospital
Prague, , Czechia
Krajska zdravotni a.s., Hospital Teplice
Teplice, , Czechia
Hopital Purpan
Toulouse, , France
Judisches Krankenhaus Berlin
Berlin, , Germany
Universitätsklinik Carl Gustav Carus Dresden
Dresden, , Germany
Klinikum der Goethe Universität Frankfurt
Frankfurt, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Oberhavelkliniken Hennigsdorf
Hennigsdorf, , Germany
Asklepios Klinikum Brandenburg
Teupitz, , Germany
Hospital Angeles del Pedregal, Camino de Santa Teresa
Mexico City, , Mexico
Hospital Medica Sur CIF-BIOTEC
Mexico City, , Mexico
Clinical Neurology Centre Sp. z o.o. (Ltd)
Krakow, , Poland
Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz
Lodz, , Poland
Independent Public Teaching Hospital No. 4 in Lublin
Lublin, , Poland
Heliodor Swiecicki Teaching Hospital of the Poznan University of Medical Sciences
Poznan, , Poland
Research Medical Complex "Your Health" Ltd
Kazan', , Russia
Moscow City Hospital #11
Moscow, , Russia
Moscow State Medical Institution City Clinical Hospital #11
Moscow, , Russia
Scientific Neurology Center RAMS
Moscow, , Russia
Municipal City Hospital #33
Nizhny Novgorod, , Russia
Federal State Institution Siberian Rettitorial Medical Center under Federal Medical-Biological Agency of Russia
Novosibirsk, , Russia
City Clinical Hospital #2
Pyatigorsk, , Russia
Institute of Human Brain RAS
Saint Petersburg, , Russia
Nikolaevskaya Hospital
Saint Petersburg, , Russia
St. Petersburg Pavlov State Medical University
Saint Petersburg, , Russia
Samara Regional Clinical Hospital n.a. Kalinin
Samara, , Russia
State Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov
Ufa, , Russia
Clinical Centre Serbia, Institute for Neurology
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical centre Kragujevac
Kragujevac, , Serbia
Clinical Center Nis, Clinic for neurology
Niš, , Serbia
Clinical Centre of Vojvodina, Clinic for neurology
Novi Sad, , Serbia
Sahlgrenska University Hospital
Gothenburg, , Sweden
Chernihiv Regional Hospital
Chernihiv, , Ukraine
Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine, Department of Neuroinfection and Multiple Sclerosis
Kharkiv, , Ukraine
Hospoital of the Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Department
Kyiv, , Ukraine
Kyiv Municipal Clinical Hospital #4
Kyiv, , Ukraine
Danylo Halytsky Lviv National Medical University
Lviv, , Ukraine
Department Of Neurosciences, Addenbrookes Hospital
Cambridge, England, United Kingdom
Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry
London, England, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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References
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Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Fisher E, Brinar VV, Giovannoni G, Stojanovic M, Ertik BI, Lake SL, Margolin DH, Panzara MA, Compston DA; CARE-MS I investigators. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1819-28. doi: 10.1016/S0140-6736(12)61769-3. Epub 2012 Nov 1.
Ziemssen T, Bass AD, Van Wijmeersch B, Eichau S, Richter S, Hoffmann F, Armstrong NM, Chirieac M, Cunha-Santos J, Singer BA. Long-term efficacy and safety of alemtuzumab in participants with highly active MS: TOPAZ clinical trial and interim analysis of TREAT-MS real-world study. Ther Adv Neurol Disord. 2025 Feb 10;18:17562864241306575. doi: 10.1177/17562864241306575. eCollection 2025.
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Riera R, Torloni MR, Martimbianco ALC, Pacheco RL. Alemtuzumab for multiple sclerosis. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD011203. doi: 10.1002/14651858.CD011203.pub3.
Dayan CM, Lecumberri B, Muller I, Ganesananthan S, Hunter SF, Selmaj KW, Hartung HP, Havrdova EK, LaGanke CC, Ziemssen T, Van Wijmeersch B, Meuth SG, Margolin DH, Poole EM, Baker DP, Senior PA. Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies. Mult Scler J Exp Transl Clin. 2023 Jan 3;9(1):20552173221142741. doi: 10.1177/20552173221142741. eCollection 2023 Jan-Mar.
Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernandez O, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9.
Kuhle J, Daizadeh N, Benkert P, Maceski A, Barro C, Michalak Z, Sormani MP, Godin J, Shankara S, Samad TA, Jacobs A, Chung L, Rӧsch N, Kaiser C, Mitchell CP, Leppert D, Havari E, Kappos L. Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS. Mult Scler. 2022 Apr;28(4):573-582. doi: 10.1177/13524585211032348. Epub 2021 Aug 11.
Coles AJ, Arnold DL, Bass AD, Boster AL, Compston DAS, Fernandez O, Havrdova EK, Nakamura K, Traboulsee A, Ziemssen T, Jacobs A, Margolin DH, Huang X, Daizadeh N, Chirieac MC, Selmaj KW. Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial. Ther Adv Neurol Disord. 2021 Apr 23;14:1756286420982134. doi: 10.1177/1756286420982134. eCollection 2021.
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Other Identifiers
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ISRCTN21534255
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTRN12608000435381
Identifier Type: REGISTRY
Identifier Source: secondary_id
CARE-MS I
Identifier Type: OTHER
Identifier Source: secondary_id
2007-001161-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAMMS323
Identifier Type: -
Identifier Source: org_study_id