Clinical trial NCT00548405: Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
Official title: A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2007-10-24
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.

Detailed description: Every participant received active treatment; there was no placebo. After Amendment 2, the 24 mg alemtuzumab dose was closed to enrollment so newly enrolled participants were randomly assigned to treatment with either 12 mg alemtuzumab or interferon beta-1a in a 2:1 ratio (that is, 2 given 12 mg alemtuzumab for every 1 given interferon beta-1a). Alemtuzumab was administered in two annual courses, once at the beginning of the study and again 1 year later. Interferon beta-1a was self-injected 3 times per week for 2 years. All participants were required to return to their study site every 3 months for neurologic assessment. In addition, safety-related laboratory tests were performed at least monthly. Participation in this study ended 2 years after the start of treatment for each participant. Additionally, participants who received alemtuzumab might be followed in the CAMMS03409 Extension Study (NCT00930553) for safety and efficacy assessments. Participants who received interferon beta-1a and completed 2 years on study might be eligible to receive alemtuzumab in the Extension Study.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent form (ICF)
* Age 18 to 55 years (inclusive) as of the date the ICF was signed
* Diagnosis of MS per update of McDonald criteria
* Onset of MS symptoms (as determined by a neurologist; could be retrospectively) within 10 years of the date the ICF was signed
* Expanded Disability Status Scale (EDSS) score 0.0 to 5.0 (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
* \>=1 MS relapse during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for \>=6 months within 10 years of the date the ICF was signed
* MRI scan demonstrating white matter lesions attributable to MS and meeting at least 1 of the following criteria, as determined by the neurologist or a radiologist: \>=9 time constant 2 (T2) lesions at least 3 millimeter (mm) in any axis; a gadolinium- (Gd-) enhancing lesion at least 3 mm in any axis plus \>=1 brain T2 lesions; and a spinal cord lesion consistent with MS plus \>=1 brain T2 lesion

Exclusion Criteria:

* Received prior therapy with alemtuzumab
* Current participation in another clinical study or previous participation in CAMMS323 (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, CARE-MS I)
* Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months. Participants who received one of these medications more than 6 months before the date the ICF was signed were eligible for study entry if approval was granted by Genzyme
* Any progressive form of MS
* History of malignancy (except basal skin cell carcinoma)
* CD4 +, CD8 +, CD19 + (that is, absolute CD3 + CD4 + , CD3 + CD8 + , or CD19 + /mm 3 ) count, absolute neutrophil count less than (\<) lower limit of normal (LLN) at screening; if abnormal cell count(s) returned to within normal limits (WNL), eligibility could be reassessed
* 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

Primary outcomes:
measure: Percentage of Participants With Sustained Accumulation of Disability (SAD)
timeFrame: Up to 2 years
measure: Annualized Relapse Rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Percentage of Participants Who Were Relapse Free at Year 2
timeFrame: Year 2
measure: Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2
timeFrame: Baseline, Year 2
measure: Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2
timeFrame: Baseline, Year 2
measure: Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2
timeFrame: Baseline, Year 2
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology Associates, P.C.
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona, Department of Neurology
state: Arizona
city: Tucson
country: United States
facility: Northwest NeuroSpecialists, PLLC
state: Arizona
city: Berkeley
country: United States
facility: East Bay Physicians Medical Group/Sutter East Bay Medical Foundation
state: California
city: La Habra
country: United States
facility: Neurology Center of North Orange County
state: California
city: Los Angeles
country: United States
facility: Department of Neurology, Keck School of Medicine, University of Southern California
state: California
city: Pasadena
country: United States
facility: Neuro-Therapeutics Inc.
state: California
city: Pasadena
country: United States
facility: Neuro-Therapeutics, Inc
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital, Anschutz Outpatient Pavilioin
state: Colorado
city: Denver
country: United States
facility: Neurological Consultants
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Jacksonville
country: United States
facility: University of Florida Neuroscience Institute
state: Florida
city: Maitland
country: United States
facility: Neurology Associates, P.A.
state: Florida
city: Pompano Beach
country: United States
facility: Neurological Associates
state: Florida
city: Sarasota
country: United States
facility: Negroski, Stein, Sutherland and Hanes Neurology
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Department of Neurology
state: Florida
city: Atlanta
country: United States
facility: Emory University, Department of Neurology
state: Georgia
city: Atlanta
country: United States
facility: Shepherd Center, Inc.
state: Georgia
city: Idaho Falls
country: United States
facility: Idaho Falls Multiple Sclerosis Center, PLLC
state: Idaho
city: Chicago
country: United States
facility: University of Chicago Medical Center, Department of Neurology
state: Illinois
city: Northbrook
country: United States
facility: Consultants in Neurology, Ltd
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University School of Medicine, Department of Neurology
state: Indiana
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology P.C.
state: Indiana
city: Des Moines
country: United States
facility: Iowa Health Physicians
state: Iowa
city: Des Moines
country: United States
facility: Ruan Neurology Clinic and Research Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center, Department of Neurology
state: Kansas
city: Lenexa
country: United States
facility: MidAmerica Neuroscience Institute
state: Kansas
city: Lexington
country: United States
facility: Associates in Neurology, PSC
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Research Foundation
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Partners Multiple Sclerosis Center/Brigham and Women's Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Springfield Neurology Associates, LLC
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Department of Neurology
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Wayne State University, School of Medicine, Department of Neurology
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group, Neurology (Previously known as Michigan Medical P.C., Neurology)
state: Michigan
city: St. Clair Shores
country: United States
facility: Michigan Neurology Associates, P.C.
state: Michigan
city: Traverse City
country: United States
facility: Northern Michigan Neurology
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Kansas City
country: United States
facility: Neurology Consultants of Kansas City, Inc.
state: Missouri
city: Missoula
country: United States
facility: Montana Neurobehavioral Specialists
state: Montana
city: Las Vegas
country: United States
facility: University of Nevada School of Medicine
state: Nevada
city: Reno
country: United States
facility: Renown Institute for Neurosciences / Renown regional Medical Center
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center
state: New Hampshire
city: Teaneck
country: United States
facility: MS Center at Holy Name Hospital
state: New Jersey
city: Alburquerque
country: United States
facility: University of New Mexico, Health Sciences Center, MS Specialty Clinic
state: New Mexico
city: Latham
country: United States
facility: Empire Neurology, PC
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital, Clinical Trials Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis
state: New York
city: Patchogue
country: United States
facility: Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University, Department of Neurology
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill, Department of Neurology
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Science, Department of Neurology
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation, Mellen Center
state: Ohio
city: Dayton
country: United States
facility: Neurology Specialists, Inc.
state: Ohio
city: Uniontown
country: United States
facility: Oak Clinic for Multiple Sclerosis
state: Ohio
city: Oklahoma City
country: United States
facility: MS Center of Oklahoma
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Hospital, Neuroscience and Pain Research
state: Pennsylvania
city: Erie
country: United States
facility: Northshore Clinical Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Kaufmann Medical Building
state: Pennsylvania
city: Providence
country: United States
facility: The Neurology Foundation, Inc.
state: Rhode Island
city: Cordova
country: United States
facility: Neurology Clinic, P.C.
state: Tennessee
city: Franklin
country: United States
facility: Advanced Neurosciences Institute
state: Tennessee
city: Franklin
country: United States
facility: Biomedical Research Alliance of NY, LLC
state: Tennessee
city: Knoxville
country: United States
facility: Hope Neurology PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Multiple Sclerosis Center
state: Tennessee
city: Dallas
country: United States
facility: Clinical Center for Multiple Sclerosis
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Neurology Center of San Antonio
state: Texas
city: Vienna
country: United States
facility: MS Center of Greater Washington, P.C.
state: Virginia
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Rockwood Clinical Research Center
state: Washington
city: Buenos Aires
country: Argentina
facility: DIABAID
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: The Wesley Research Institute
state: Queensland
city: Southport
country: Australia
facility: Griffith School of Medicine, Gold Coast Campus, Griffith University
state: Queensland
city: Woodville South
country: Australia
facility: Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital, MS Education & Research, Department of Clinical Neurosciences
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital, Department of Neurology
state: Victoria
city: Concord
country: Australia
facility: Concord Repatriation General Hospital, Neurosciences Department
city: Kogarah
country: Australia
facility: Southern Neurology
city: Liverpool
country: Australia
facility: Liverpool Hospital, Neurology Department
city: Wien
country: Austria
facility: AKH Wien, Universitätsklinikum für Neurologie
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint-Luc, Neurology
city: Esneux
country: Belgium
facility: CHU Ourthe Amblève, Neurology
city: Leuven
country: Belgium
facility: University Hospital Leuven, Campus Gasthuisberg, Neurology
city: Recife
country: Brazil
facility: Hospital da Restauracao
state: PE
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas PUC-RS
state: RS
city: Sao Paulo
country: Brazil
facility: Hospital de Clínicas USP
city: Sao Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Sao Paulo
city: Vancouver
country: Canada
facility: UBC Hospital
state: British Columbia
city: Kingston
country: Canada
facility: Multiple Sclerosis Clinic, Connell 7, Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre- University Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Gatineau
country: Canada
facility: Centre de Sante et de Services Sociaux de Gatineau-Hull Hospital
state: Quebec
city: Greenfield park
country: Canada
facility: Clinique Neuro rive-sud, Recherche sepmus inc
state: Quebec
city: Montreal
country: Canada
facility: Hospital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institute and Hospital
state: Quebec
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre Rijeka, Clinic for Neurology
city: Varazdin
country: Croatia
facility: General Hospital Varazdin, Department of neurology
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Sestre Milosrdnice
city: Zagreb
country: Croatia
facility: General Hospital " Sveti Duh", Department of neurology
city: Hradec Kralove
country: Czech Republic
facility: MS Center, Department of Neurology
city: Pekarska
country: Czech Republic
facility: St. Anne's University Hospital Brno
city: Praha 2
country: Czech Republic
facility: Department of Neurology 1st Faculty of Medicine and General Teaching Hospital, MS Center
city: Teplice
country: Czech Republic
facility: Krajska zdravotni a.s. - Hospital Teplice
city: Aarhus
country: Denmark
facility: Århus Universitetshospital, Scleroseklinikken, Århus Sygehus
city: København
country: Denmark
facility: Scleroseklinikken, Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand, Hôpital Gabriel Montpied
city: Dijon Cedex
country: France
facility: Hôpital General, Service de Neurologie
city: Lille Cedex
country: France
facility: Hospital Roger Salengro
city: Paris
country: France
facility: Hôpital Pitié Salpétrière, Service de Neurologie
city: Rennes Cedex
country: France
facility: Sevice de Neurologie
city: Strasbourg Cedex
country: France
facility: Hôpital Civil, Departement de Neurologie
city: Bayreuth
country: Germany
facility: Krankenhaus Hohe Warte, Betriebsstätte der Bayreuth
city: Berlin
country: Germany
facility: Judisches Krankenhaus Berlin
city: Berlin
country: Germany
facility: Neurologisches Fachzentrum Berlin
city: Bonn
country: Germany
facility: Neurologische Universitätsklinik Bonn
city: Dresden
country: Germany
facility: Multiple Sklerose Zentrum am, Zentrum für klinische Neurowissenschaften, Neurologische Uniklinik Dresden
city: Hamburg
country: Germany
facility: Asklepios Klinic Barmbek
city: Hannover
country: Germany
facility: Medizinische Hochshule Hannover
city: Hennigsdorf
country: Germany
facility: Oberhavelkliniken Hennigsdorf
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt, Neurologische Klinik
city: Muenchen
country: Germany
facility: Klinikum Rechts der Isar, Klinik für Neurologie
city: Rostock
country: Germany
facility: Klinik und Poliklinik fur Neurologie der Universitat Rockstock
city: Ulm
country: Germany
facility: Universitatsklinik Ulm
city: Wermsdorf
country: Germany
facility: Fachkrankenhaus Hubertusburg
city: Jerusalem
country: Israel
facility: Hadassah Medical Center Ein Karem
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center, Department of Neurology
city: Tel Hashomer
country: Israel
facility: Sheba Medical Centre
city: Cagliari
country: Italy
facility: Ospedale Binaghi - Centro Sclerosi Multipla
city: Gallarate
country: Italy
facility: Ospedale S. Antonio Abate di Gallarate
city: Genova
country: Italy
facility: Università di Genova Dipartimento di Neuroscienze Oftalmologia e Genetica
city: Montichiari
country: Italy
facility: Ospedale Civile di Brescia c/o Ospedale Richiedei, Centro di riferimento per la Sclerosi Multiple
city: Orbassano
country: Italy
facility: Ospedale San Luigi di Orbassano
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea Neurologia
city: Delegacion
country: Mexico
facility: Hospital Medica Sur CIF-BIOTEC
state: Tlalpan
city: Chihuahua
country: Mexico
facility: Unidad de Investigación en Salud de Chihuahua, S.C.
city: Mexico City
country: Mexico
facility: Hospital Angeles del Pedregal; Camino a Santa Teresa
city: Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Sittard
country: Netherlands
facility: Orbis Medisch Centrum, Department of Neurology
city: Lodz
country: Poland
facility: Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz
city: Lublin
country: Poland
facility: Independent Public Teaching Hospital No. 4 in Lublin
city: Poznan
country: Poland
facility: Heliodor Swiecicki Teaching Hospital of the Poznan, University of Medical Sciences
city: Kazan
country: Russian Federation
facility: Research Medical Complex "Your Health" Ltd
city: Moscow
country: Russian Federation
facility: Institution of the Russian Academy of Medical Sciences, "Neurology Scientific Center under RAMS"
city: Moscow
country: Russian Federation
facility: Moscow State Medical Institution City Clinical Hospital #11, Moscow City Center for Multiple Sclerosis
city: Moscow
country: Russian Federation
facility: Moscow State Public Medical Institution, City Clinical Hospital #11
city: Nizhniy Novgorod
country: Russian Federation
facility: Municipal Treatment and Prevention Institution, "City Hospital #33"
city: Novosibirsk
country: Russian Federation
facility: Federal State Institution: Siberian District Medical Center
city: Samara
country: Russian Federation
facility: State Medical Institution, "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
city: St. Petersburg
country: Russian Federation
facility: Institution of the Russian Academy of Sciences, "Institute of the Human Brain n.a. N.P. Bekhtereva within the Russian Academy of Sciences"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Pavlov State Medical University, Department of Neurology and Neurosurgery with a Clinic
city: St. Petersburg
country: Russian Federation
facility: St.Petersburg State Medical Institution, "City Multispecialty Hospital #2"
city: St. Petersburg
country: Russian Federation
facility: St.Petersburg State Medical Institution, "Nikolayevskaya Hospital"
city: Belgrade
country: Serbia
facility: Clinic of Neurology, Clinical Centre of Serbia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Kragujevac
country: Serbia
facility: Clinical Centre of Kragujevac
city: Novi Sad
country: Serbia
facility: Clinical Centre Vojvodina Institute of Neurology
city: Barcelona
country: Spain
facility: Servicio de Neurología Hospital Vall d'Hebron Paseo de Vall d'Hebron
city: Madrid
country: Spain
facility: Servicio de Neurología Hospital Clínico San Carlos
city: Malaga
country: Spain
facility: Servicio de Neurología Hospital Carlos Haya
city: Sevilla
country: Spain
facility: Servicio de Neurología Hospital Virgen de la Macarena
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Neurologkliniken
city: Umea
country: Sweden
facility: Norrlands Universitets sjukhus
city: Kharkov
country: Ukraine
facility: Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine
city: Kyiv
country: Ukraine
facility: Kyiv Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System
city: Lviv
country: Ukraine
facility: Danylo Halytsky Lviv National Medical University, Department of Neurology
city: Cambridge
country: United Kingdom
facility: Department Of Neurosciences, Addenbrookes Hospital
state: England
city: London
country: United Kingdom
facility: Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science Barts and The London School of Medicine and Dentistry
state: England
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust, Clinical Trials Unit
city: Sheffield
country: United Kingdom
facility: Department of Neurology Glossop Road, Royal Hallamshire Hospital
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DA; CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1829-39. doi: 10.1016/S0140-6736(12)61768-1. Epub 2012 Nov 1.
citation: 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.
citation: 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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