Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One (CARE-MS I)

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

The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Biological: Interferon beta-1a; Biological: Alemtuzumab

Detailed Description

Every participant had received active treatment; there was no placebo. Participants who qualified were randomly assigned to treatment with either alemtuzumab or SC interferon beta-1a at a 2:1 ratio (that is, 2 given 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 CAMMS03409 (NCT00930553) an extension study for safety and efficacy assessments. Participants who received interferon beta-1a and completed 2 years on study might be eligible to receive alemtuzumab on the extension study.

• Study Type: Interventional
• Enrollment (Actual): 581
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • DIABAID
• Australia
  • Concord, Australia
    • Concord Repatriation General Hospital
  • Westmead, Australia
    • Westmead Hospital
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • The Wesley Research Institute
    • Southport, Queensland, Australia
      • Griffith University School of Medicine
  • South Australia
    • Woodville South, South Australia, Australia
      • The Queen Elizabeth Hospital
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital, Department of Neurology, Ward 4 East
• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil
      • Hospital da Restauracao, Av Governador Agamenon Magalhaes
  • RS
    • Porto Alegre, RS, Brazil
      • Hospital São Lucas PUC-RS
  • SP
    • Sao Paulo, SP, Brazil
      • Hospital de Clínicas USP
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary and Foothills Medical Cenre
  • British Columbia
    • Vancouver, British Columbia, Canada
      • UBC Hospital
  • Ontario
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital, General Campus
  • Quebec
    • Gatineau, Quebec, Canada
      • Clinique Nuero-outaouais
    • Greenfield park, Quebec, Canada
      • Clinique Neuro rive-sud, Recherche Sepmus, Inc.
• Croatia
  • Rijeka, Croatia
    • Clinical Hospital Centre Rijeka
  • Varazdin, Croatia
    • General Hospital Varazdin
  • Zagreb, Croatia
    • Clinical Hospital Centre Zagreb
  • Zagreb, Croatia
    • General Hospital "Sveti Duh"
  • Zagreb, Croatia
    • Clinical Hospital Centre "Sestre Milosrdnice"
• Czech Republic
  • Praha 2, Czech Republic
    • Department of Neurology, 1st Faculty of Medicine and General Teaching Hospital
  • Teplice, Czech Republic
    • Krajska zdravotni a.s., Hospital Teplice
• France
  • Toulouse, France
    • Hopital Purpan
• Germany
  • Berlin, Germany
    • Jüdisches Krankenhaus Berlin
  • Dresden, Germany
    • Universitätsklinik Carl Gustav Carus Dresden
  • Frankfurt, Germany
    • Klinikum der Goethe Universität Frankfurt
  • Hannover, Germany
    • Medizinische Hochschule Hannover
  • Hennigsdorf, Germany
    • Oberhavelkliniken Hennigsdorf
  • Teupitz, Germany
    • Asklepios Klinikum Brandenburg
• Mexico
  • Mexico City, Mexico
    • Hospital Angeles del Pedregal, Camino de Santa Teresa
  • Mexico City, Mexico
    • Hospital Medica Sur CIF-BIOTEC
• Poland
  • Cracow, Poland
    • Clinical Neurology Centre Sp. z o.o. (Ltd)
  • Lodz, Poland
    • Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz
  • Lublin, Poland
    • Independent Public Teaching Hospital No. 4 in Lublin
  • Poznan, Poland
    • Heliodor Swiecicki Teaching Hospital of the Poznan University of Medical Sciences
• Russian Federation
  • Kazan, Russian Federation
    • Research Medical Complex "Your Health" Ltd
  • Moscow, Russian Federation
    • Moscow City Hospital #11
  • Moscow, Russian Federation
    • Moscow State Medical Institution City Clinical Hospital #11
  • Moscow, Russian Federation
    • Scientific Neurology Center RAMS
  • Nizhniy Novgorod, Russian Federation
    • Municipal City Hospital #33
  • Novosibirsk, Russian Federation
    • Federal State Institution Siberian Rettitorial Medical Center under Federal Medical-Biological Agency of Russia
  • Pyatigorsk, Russian Federation
    • City Clinical Hospital #2
  • Samara, Russian Federation
    • Samara Regional Clinical Hospital n.a. Kalinin
  • St. Petersburg, Russian Federation
    • St. Petersburg Pavlov State Medical University
  • St. Petersburg, Russian Federation
    • Nikolaevskaya Hospital
  • St. Petersburg, Russian Federation
    • Institute of Human Brain Ras
  • Ufa, Russian Federation
    • State Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov
• Serbia
  • Belgrade, Serbia
    • Military Medical Academy
  • Belgrade, Serbia
    • Clinical Centre Serbia, Institute for Neurology
  • Kragujevac, Serbia
    • Clinical Centre Kragujevac
  • Nis, Serbia
    • Clinical Center Nis, Clinic for neurology
  • Novi Sad, Serbia
    • Clinical Centre of Vojvodina, Clinic for neurology
• Sweden
  • Goteborg, Sweden
    • Sahlgrenska University Hospital
• Ukraine
  • Chernihiv, Ukraine
    • Chernihiv Regional Hospital
  • Kharkiv, Ukraine
    • Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine, Department of Neuroinfection and Multiple Sclerosis
  • Kyiv, Ukraine
    • Hospoital of the Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Department
  • Kyiv, Ukraine
    • Kyiv Municipal Clinical Hospital #4
  • Lviv, Ukraine
    • Danylo Halytsky Lviv National Medical University
• United Kingdom
  • Sheffield, United Kingdom
    • Royal Hallamshire Hospital
  • England
    • Cambridge, England, United Kingdom
      • Department Of Neurosciences, Addenbrookes Hospital
    • London, England, United Kingdom
      • Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry
  • Wales
    • Cardiff, Wales, United Kingdom
      • University Hospital of wales
• United States
  • Alabama
    • Cullman, Alabama, United States
      • North Central Neurology Associates, P.C.
  • Arizona
    • Phoenix, Arizona, United States
      • Barrow Neurological Institute, St. Joseph's Hospital & Medical Center
    • Scottsdale, Arizona, United States
      • Mayo Clinic Arizona
    • Tucson, Arizona, United States
      • Northwest NeuroSpecialists, PLLC
  • Colorado
    • Fort Collins, Colorado, United States
      • Advanced Neurosciences Research
  • Florida
    • Pompano Beach, Florida, United States
      • Neurological Associates
    • Tampa, Florida, United States
      • Axiom Clinical Research of Florida
  • Idaho
    • Idaho Falls, Idaho, United States
      • Idaho Falls Multiple Sclerosis Center, PLLC
  • Illinois
    • Northbrook, Illinois, United States
      • Consultants in Neurology, Ltd.
  • Indiana
    • Fort Wayne, Indiana, United States
      • Fort Wayne Neurological Center
  • Kansas
    • Kansas City, Kansas, United States
      • University of Kansas Medical Center
    • Lenexa, Kansas, United States
      • MidAmerican Neuroscience Institute
  • Kentucky
    • Lexington, Kentucky, United States
      • Associates in Neurology, PSC
    • Louisville, Kentucky, United States
      • University of Louisville Research Foundation
  • Louisiana
    • Shreveport, Louisiana, United States
      • Louisiana State University Health Sciences Center
  • Massachusetts
    • Worcester, Massachusetts, United States
      • UMass Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States
      • University of Michigan Health System
    • Detroit, Michigan, United States
      • Wayne State University
  • Nevada
    • Las Vegas, Nevada, United States
      • University of Nevada School of Medicine
  • New Hampshire
    • Lebanon, New Hampshire, United States
      • Dartmouth-Hitchcock Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States
      • University of New Mexico, Health Sciences Center, MS Specialty Clinic
  • New York
    • Latham, New York, United States
      • Empire Neurology
    • Patchogue, New York, United States
      • Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.
    • Rochester, New York, United States
      • University of Rochester Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States
      • Carolinas Medical Center (CMC), Neurosciences & Spine Institute (NSSI)
  • Ohio
    • Columbus, Ohio, United States
      • The Ohio State University Medical Center, Multiple Sclerosis Center
    • Uniontown, Ohio, United States
      • Oak Clinic for Multiple Sclerosis
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • MS Center of Oklahoma
  • Pennsylvania
    • Allentown, Pennsylvania, United States
      • Lehigh Valley Hospital Neurosciences and Pain Research
  • Tennessee
    • Franklin, Tennessee, United States
      • Advanced Neurosciences Institute
    • Franklin, Tennessee, United States
      • Biomedical Research Alliance of NY, LLC
    • Knoxville, Tennessee, United States
      • Hope Neurology PC
  • Texas
    • Houston, Texas, United States
      • Baylor College of Medicine, Maxine Mesinger MS Clinic
    • Round Rock, Texas, United States
      • Central Texas Neurology
    • San Antonio, Texas, United States
      • Integra Clinical Research
    • San Antonio, Texas, United States
      • Neurology Center of San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Given written/signed informed consent
• 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:

• Received prior therapy for MS other than corticosteroids, for example, alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, and mitoxantrone
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interferon Beta-1a	Biological: 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 Names: Rebif®
Experimental: Alemtuzumab	Biological: 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.; Other Names: Lemtrada

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Relapse Rate	Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.	Up to 2 years
Percentage of Participants With Sustained Accumulation of Disability (SAD)	EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least next 2 scheduled assessments, that is, 6 consecutive months. Onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Were Relapse Free at Year 2	Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.	Year 2
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2	MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.	Baseline, Year 2
Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2	Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)*100/ (lesion volume at Baseline).	Baseline, Year 2
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2	EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.	Baseline, Year 2

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company
• Collaborators: Bayer

Publications and helpful links

General Publications

• 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.
• 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.
• Horakova D, Boster A, Bertolotto A, Freedman MS, Firmino I, Cavalier SJ, Jacobs AK, Thangavelu K, Daizadeh N, Poole EM, Baker DP, Margolin DH, Ziemssen T; CARE-MS I, CARE-MS II, and CAMMS03409 Investigators. Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Mult Scler J Exp Transl Clin. 2020 Dec 18;6(4):2055217320972137. doi: 10.1177/2055217320972137. eCollection 2020 Oct-Dec.
• Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x.
• Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernandez O, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25.
• Van Wijmeersch B, Singer BA, Boster A, Broadley S, Fernandez O, Freedman MS, Izquierdo G, Lycke J, Pozzilli C, Sharrack B, Steingo B, Wiendl H, Wray S, Ziemssen T, Chung L, Margolin DH, Thangavelu K, Vermersch P. Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Mult Scler. 2020 Nov;26(13):1719-1728. doi: 10.1177/1352458519881759. Epub 2019 Nov 1.
• Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25.
• Li Z, Richards S, Surks HK, Jacobs A, Panzara MA. Clinical pharmacology of alemtuzumab, an anti-CD52 immunomodulator, in multiple sclerosis. Clin Exp Immunol. 2018 Dec;194(3):295-314. doi: 10.1111/cei.13208. Epub 2018 Oct 1.
• Arnold DL, Fisher E, Brinar VV, Cohen JA, Coles AJ, Giovannoni G, Hartung HP, Havrdova E, Selmaj KW, Stojanovic M, Weiner HL, Lake SL, Margolin DH, Thomas DR, Panzara MA, Compston DA; CARE-MS I and CARE-MS II Investigators. Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon beta-1a in MS. Neurology. 2016 Oct 4;87(14):1464-1472. doi: 10.1212/WNL.0000000000003169. Epub 2016 Sep 2.
• 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.
• 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.
• Havrdova E, Arnold DL, Cohen JA, Hartung HP, Fox EJ, Giovannoni G, Schippling S, Selmaj KW, Traboulsee A, Compston DAS, Margolin DH, Thangavelu K, Rodriguez CE, Jody D, Hogan RJ, Xenopoulos P, Panzara MA, Coles AJ; CARE-MS I and CAMMS03409 Investigators. Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy. Neurology. 2017 Sep 12;89(11):1107-1116. doi: 10.1212/WNL.0000000000004313. Epub 2017 Aug 23. Erratum In: Neurology. 2018 Apr 17;90(16):755.

Helpful Links

• http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003718/WC500150521.pdf

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: September 13, 2007
• First Submitted That Met QC Criteria: September 13, 2007
• First Posted (Estimate): September 17, 2007

Study Record Updates

• Last Update Posted (Estimate): November 24, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Multiple Sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Adjuvants, Immunologic; Interferons; Interferon beta-1a; Interferon-beta; Alemtuzumab
• Other Study ID Numbers: CAMMS323; ISRCTN21534255 (Registry Identifier: ISRCTN); ACTRN12608000435381 (Registry Identifier: ANZCTR); CARE-MS I (Other Identifier: NMSS); 2007-001161-14 (EudraCT Number)