An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

This open-label, rater-blinded extension study enrolled participants who had relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab (CAMMS223 [NCT00050778], CAMMS323 [NCT00530348] also known as CARE-MS I, or CAMMS324 [NCT00548405] also known as CARE-MS II). The purposes of this study were:

1. To examine the long term safety and efficacy of alemtuzumab treatment in participants who received alemtuzumab as their study treatment in one of the prior studies.
2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for participants who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies.
3. To determine the safety and efficacy of additional "as needed" alemtuzumab treatment courses. This applied both to participants who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Biological: alemtuzumab

Detailed Description

Alemtuzumab treatment was on a fixed schedule of two treatment courses a year apart for participants who received Rebif® in one of the prior Genzyme-sponsored studies of alemtuzumab or on an as needed schedule (e.g. due to documented evidence of resumed Multiple Sclerosis [MS] activity) for participants who had already completed a fixed schedule of treatment with alemtuzumab in one of the prior Genzyme-sponsored studies. There was no comparison treatment in this study. All participants were required to return to their study site every 3 months for neurologic and other assessments. In addition, safety-related laboratory tests and surveys were performed at least monthly. Participation in the extension study was at least 48 months from enrollment. Study duration could be extended to allow participants to remain in the study until a follow-up study was available in their country or through month 60 (month 72 in USA), whichever occurred first.

• Study Type: Interventional
• Enrollment (Actual): 1314
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • DIABAID
• Australia
  • Auchenflower QLD, Australia
    • The Wesley Research Institute
  • Woodville, SA, Australia
    • The Queen Elizabeth Hospital
  • New South Wales
    • Concord, New South Wales, Australia
      • Concord Repatriation General Hospital
    • Kogarah, New South Wales, Australia
      • Southern Neurology
    • Liverpool, New South Wales, Australia
      • Liverpool Hospital
    • Westmead, New South Wales, Australia
      • Westmead Hospital
  • Queensland
    • Southport, Queensland, Australia
      • Gold Coast Hospital
  • Tasmania
    • Hobart, Tasmania, Australia
      • Royal Hobart Hospital
  • Victoria
    • Fitzroy, Victoria, Australia
      • St. Vincent's Hospital
    • Heidelberg, Victoria, Australia
      • Austin Health
    • Parkville, Victoria, Australia
      • Royal Melbourne Hospital
• Austria
  • Vienna, Austria
    • AKH Wien-Universitätskliniken für Neurologie
• Belgium
  • Brussel, Belgium
    • Cliniques Universitaires Saint-Luc
  • Esneux, Belgium
    • CHU Ourthe Amblève
  • Leuven, Belgium
    • University Hospital Leuven, Campus Gasthuisberg
• Brazil
  • Porto Alegre, Brazil
    • Hospital Mae de Deus
  • Recife, PE, Brazil
    • Hospital da Restauração, Neurology department
  • São Paulo, SP, Brazil
    • Irmandade da Santa Casa de Misericórdio de São Paulo, Neurology department
  • São Paulo,SP, Brazil
    • Hospital das Clínicas da Faculdade de Medicina da USP, Neurology department
• Canada
  • London, ON, Canada
    • London Health Sciences Centre - University Hospital
  • Ottawa, Ontario, Canada
    • The Ottawa Hospital - MS Research
  • Vancouver, BC, Canada
    • University of British Columbia
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary, Department of Neurology
  • Ontario
    • Kingston, Ontario, Canada
      • Kingston General Hospital MS Clinic
  • Quebec
    • Gatineau, Quebec, Canada
      • Clinique Neuro-Outaouais
    • Greenfield Park, Quebec, Canada
      • Recherche Sepmus, Inc.
    • Montreal, Quebec, Canada
      • Hopital Maisonneuve-Rosemont
• Croatia
  • Osijek, Croatia
    • Clinical Hospital Osijek
  • Rijeka, Croatia
    • Clinical Hospital Centre Rijeka
  • Varazdin, Croatia
    • General Hospital Varazdin, Department for Neurology
  • Zagreb, Croatia
    • Clinical Hospital Centre Zagreb
  • Zagreb, Croatia
    • Clinical Hospital Sveti Duh
  • Zagreb, Croatia
    • Clinical Hospital Centre "Sestre Milosrdnice"
• Czechia
  • Brno, Czechia
    • St. Anne's University Hospital Brno
  • Hradec Kralove, Czechia
    • University Hospital Hradec Kralove
  • Prague, Czechia
    • General Hospital, 128 21 Praha 2
  • Teplice, Czechia
    • Hospital Teplice, Neurology Department, MS centrum
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet Department of Neurology
  • Århus C, Denmark
    • Aarhus Sygehus
• France
  • Dijon Cedex, France
    • Hôpital Général
  • Paris Cedex 13, France
    • Groupe Hospitalier Pitié-Salpêtrière, Fédération de Maladies du System Nerveux Central
  • Rennes Cedex 9, France
    • CHU Pontchaillou
  • Strasbourg Cedex, France
    • Hôpital Civil
  • Toulouse Cedex 9, France
    • CHU de Toulouse, Hôpital Purpan
• Germany
  • Berlin-Mitte, Germany
    • Jüdisches Krankenhaus Berlin
  • Dresden, Germany
    • Universitätsklinik Carl Gustav Carus Dresden
  • Frankfurt am Main, Germany
    • Klinikum der JW Goethe Universität
  • Hamburg, Germany
    • Asklepios Klinik Barmbek
  • Hannover, Germany
    • Medizinische Hochschule Hannover
  • Hennigsdorf, Germany
    • Oberhavel Klinicum GmbH - Krankenhaus Hennigsdorf
  • Ingolstadt, Germany
    • Klinikum Ingolstadt
  • München, Germany
    • Klinikum rechts der Isar
  • Rostock, Germany
    • Medizinische Fakultät der Universität Rostock,Zentrum für Nervenheilkunde
  • Ulm, Germany
    • Universitätsklinikum Ulm, Klinik für Neurologie im RKU
  • Wermsdorf, Germany
    • Fachkrankenhaus Hubertusburg GmbH, Klinik für Neurologie und Neurologische Intensivmedizin
  • DE
    • Bonn, DE, Germany
      • Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn
• Israel
  • Ein Karem, Jerusalem, Israel
    • Hadassah Medical Center Ein Karem
  • Ramat Gan, Israel
    • Sheba Medical Center
  • Tel Aviv, Israel
    • Sourasky Tel Aviv Medical Center
• Italy
  • Cagliari, Italy
    • Università di Cagliari
  • Gallarate (Varese), Italy
    • Ospedale S. Antonio Abate di Gallarate
  • Orbassano (TO), Italy
    • Ospedale S. Luigi Gonzaga
  • Roma, Italy
    • Università degli studi di Roma "La Sapienza"
• Mexico
  • Chihuahua, CHH, Mexico
    • Unidad de Investigación en Salud
  • Mexico City, DFE, Mexico
    • Médica Sur
• Netherlands
  • Den Bosch, Netherlands
    • Jeroen Bosch Ziekenhuis
  • Sittard-Geleen, Netherlands
    • Orbis Medisch Concern
• Poland
  • Krakow, Poland
    • Centrum Neurologii Klinicznej Sp. Zo.o.
  • Lodz, Poland
    • Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny Nr1 im. Norberta Barlickiego
  • Lublin, Poland
    • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Poznan, Poland
    • Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Med. im. Karola Marcinkowskiego w Poznaniu
  • Warsaw, Poland
    • Institute of Psychiatry and Neurology/Instytut Psychiatrii i Neurologii
• Russian Federation
  • Kazan, Russian Federation
    • Research Medical Complex "Your Health" Ltd
  • Moscow, Russian Federation
    • Moscow State Public Medical Institution Clinical Hospital #11, Neurology Department
  • Moscow, Russian Federation
    • Neurology Research Center under the Russian Academy of Medical Sciences
  • Moscow, Russian Federation
    • Russian State Medical University, Department of Neurology and Neurosurgery
  • Nizhny Novgorod, Russian Federation
    • Municipal Treatment and Prevention Institution, City Hospital #33
  • Novosibirsk, Russian Federation
    • Federal State Public Medical Institution: Siberian District Medical Center under the Federal Agency
  • Pyatigorsk, Russian Federation
    • Municipal Public Medical Institution: City Hospital #2 of Pyatigorsk, Neurology Department
  • Samara, Russian Federation
    • Samara Regional Clinical Hospital n.a. Kalinin
  • St. Petersburg, Russian Federation
    • Institute of Human Brain RAS, Laboratory of Neuroimmunology
  • St. Petersburg, Russian Federation
    • St Petersburg State Pavlov Medical University, Dept of Neurology and Neurosurgery with a Hospital
  • St. Petersburg, Russian Federation
    • St. Petersburg General Hospital #2, Neurology Department #2
  • St. Petersburg, Russian Federation
    • St. Petersburg State Public Medical Institution: Nikolayevskaya Hospital
  • Ufa, Russian Federation
    • State Public Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov
• Serbia
  • Belgrade, Serbia
    • Clinical Centre Serbia, Institute of Neurology,Dr.Subotica 6,Belgrade
  • Belgrade, Serbia
    • Military Medical Academy, Institute of Neurology
  • Kragujevac, Serbia
    • Clinical Centre Kragujevac, Clinic of Neurology
  • Nis, Serbia
    • Clinical Centre Nis, Clinic of Neurology
  • Novi Sad, Serbia
    • Clinical Centre Vojvodina
• Spain
  • Barcelona, Spain
    • Hospital Universitario Vall d' Hebrón
  • Madrid, Spain
    • Hospital Clínico Universitario San Carlos
  • Málaga, Spain
    • Hospital Carlos Haya, Neurology Service
  • Seville, Spain
    • Hospital Virgen Macarena
• Sweden
  • Göteborg, Sweden
    • SU/Östra sjukhuset
  • Umeå, Sweden
    • Norrlands Universitets sjukhus
• Ukraine
  • Kharkov, Ukraine
    • Institute of Neurology, Psychiatry and Narcology under the AMS of Ukraine, Dep of Neuroinfection& MS
  • Kiev, Ukraine
    • Kiev Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System
  • Kiev-21, Ukraine
    • Hospital of Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Dept.
  • Lviv, Ukraine
    • Lviv National Medical University n.a. Danylo Galytsky, Department of Neurology
• United Kingdom
  • Bristol, United Kingdom
    • Frenchay Hospital
  • Cambridge, United Kingdom
    • Addenbrookes Hospital
  • Cardiff, United Kingdom
    • University Hospital of Wales, Dept of Neurology
  • London, United Kingdom
    • Royal London Hospital
  • Salford, United Kingdom
    • Salford Royal NHS Foundation Trust
  • Sheffield, United Kingdom
    • Royal Hallamshire Hospital
• United States
  • Alabama
    • Cullman, Alabama, United States
      • North Central Neurology Associates, P.C.
  • Arizona
    • Phoenix, Arizona, United States
      • Hope Research Institute
    • Phoenix, Arizona, United States
      • St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute
    • Scottsdale, Arizona, United States
      • Mayo Clinic Arizona (Scottsdale)
    • Tucson, Arizona, United States
      • Northwest NeuroSpecialists, PLLC
  • California
    • Berkeley, California, United States
      • East Bay Physicians Medical Group/ Sutter East Bay Medical Foundation
    • La Habra, California, United States
      • Neurology Center North Orange County
    • Los Angeles, California, United States
      • University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center
    • Pasadena, California, United States
      • Neuro-Therapeutics, Inc.
    • Stanford, California, United States
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States
      • University of Colorado Health Science Center - Aurora
    • Fort Collins, Colorado, United States
      • Advanced Neurology of Colorado
  • Connecticut
    • New Haven, Connecticut, United States
      • Yale MS Research Center
  • District of Columbia
    • Washington, D.C., District of Columbia, United States
      • The George Washington University Medical Faculty Associates
  • Florida
    • Jacksonville, Florida, United States
      • University of Florida Neuroscience Institute
    • Maitland, Florida, United States
      • Neurology Associates, P.A.
    • Pompano Beach, Florida, United States
      • Neurological Associates
    • Sarasota, Florida, United States
      • Negroski, Stein, Sutherland and Hanes Neurology
    • Tampa, Florida, United States
      • Axiom Clinical Research of Florida
    • Tampa, Florida, United States
      • University of South Florida College of Medicine
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University Department of Neurology
    • Atlanta, Georgia, United States
      • Shepherd Center Multiple Sclerosis Institute
  • Illinois
    • Chicago, Illinois, United States
      • University of Chicago Medical Center
    • Northbrook, Illinois, United States
      • Consultants in Neurology, Ltd
  • Indiana
    • Fort Wayne, Indiana, United States
      • Fort Wayne Neurological Center
    • Indianapolis, Indiana, United States
      • Indiana University Multiple Sclerosis Center
  • Iowa
    • Des Moines, Iowa, United States
      • Iowa Health Physicians
    • Des Moines, Iowa, United States
      • Ruan Neurology Clinic and Clinical Research Center, Mercy Medical Center
  • Kansas
    • Kansas City, Kansas, United States
      • University of Kansas Medical Center, Department of Neurology
    • Lenexa, Kansas, United States
      • MidAmerica Neuroscience Institute
  • Kentucky
    • Lexington, Kentucky, United States
      • Associates in Neurology, P.S.C.
    • Louisville, Kentucky, United States
      • Kentucky Neuroscience Research
  • Maryland
    • Baltimore, Maryland, United States
      • University of Maryland, Maryland Center for MS
  • Massachusetts
    • Boston, Massachusetts, United States
      • The MS Center at St. Elizabeth's
    • Worcester, Massachusetts, United States
      • Umass Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States
      • University of Michigan Medical School
    • Clinton, Michigan, United States
      • Michigan Neurology Association
    • Detroit, Michigan, United States
      • Wayne State University, The School of Medicine, Department of Neurology
    • Grand Rapids, Michigan, United States
      • Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS Clinic
    • Traverse City, Michigan, United States
      • Northern Michigan Neurology
  • Missouri
    • Kansas City, Missouri, United States
      • Saint Luke's Brain & Stroke Institute
  • Nevada
    • Reno, Nevada, United States
      • Renown Institute for Neurosciences
  • New Hampshire
    • Lebanon, New Hampshire, United States
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Teaneck, New Jersey, United States
      • MS Center at Holy Name Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States
      • University of New Mexico, Dept. of Neurology
  • New York
    • Latham, New York, United States
      • Empire Neurology P.C.
    • Mineola, New York, United States
      • Winthrop University Hospital Multiple Sclerosis Treatment Center
    • New York, New York, United States
      • MS Care Center at NYUMC and HJD
    • New York, New York, United States
      • The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
    • Patchogue, New York, United States
      • South Shore Neurologic Associates, P.C.
    • Rochester, New York, United States
      • Rochester Multiple Sclerosis Center
    • Syracuse, New York, United States
      • SUNY Upstate Medical University, Department of Neurology
  • North Carolina
    • Chapel Hill, North Carolina, United States
      • The University of North Carolina at Chapel Hill
    • Winston-Salem, North Carolina, United States
      • Wake Forest University Health Science Department of Neurology
  • Ohio
    • Cleveland, Ohio, United States
      • Cleveland Clinic Foundation
    • Uniontown, Ohio, United States
      • Oak Clinic for Multiple Sclerosis
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • OMRF Multiple Sclerosis Center of Excellence
  • Pennsylvania
    • Allentown, Pennsylvania, United States
      • Lehigh Valley Hospital Neurosciences and Pain Research
  • Rhode Island
    • Providence, Rhode Island, United States
      • Rhode Island Hospital MS Center - The Neurology Foundation, Inc
  • Tennessee
    • Cordova, Tennessee, United States
      • Neurology Clinic PC
    • Franklin, Tennessee, United States
      • Advanced Neurosciences Institute
    • Knoxville, Tennessee, United States
      • Hope Neurology
    • Nashville, Tennessee, United States
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States
      • Baylor College of Medicine, Maxine Mesinger MS Clinic
    • Round Rock, Texas, United States
      • Central Texas Neurology Consultants
    • San Antonio, Texas, United States
      • Integra Clinical Research
    • San Antonio, Texas, United States
      • Neurology Center of San Antonio
  • Virginia
    • Vienna, Virginia, United States
      • MS Center of Greater Washington
  • Washington
    • Seattle, Washington, United States
      • Swedish Medical MS Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1.Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period, and had not subsequently received disease modifying treatments (other than glatiramer acetate or interferon beta); or
• 2.Received Rebif® in CAMMS323 or CAMMS324, completed the 2-year study period, and had not subsequently received alternative disease modifying treatments (other than glatiramer acetate or another interferon beta); or
• 3.Participated in CAMMS223.
• NOTE: Criteria 1 and 2 above meant that participants who enrolled in CAMMS323 or CAMMS324 but did not complete the 2-year study period or went on to receive non-study drug DMTs after randomization were not eligible for inclusion in the Extension Study. Participants who enrolled in CAMMS324 after participation in CAMMS223 must meet criteria 1 or 2 to be eligible for inclusion in the Extension Study.

Exclusion Criteria:

• Any alemtuzumab participant from CAMMS223, CAMMS323, or CAMMS324 who had received alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies), or was participating in any other investigational study, unless approved by Genzyme. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab retreatment.
• Any Rebif® participants from CAMMS223, CAMMS323, or CAMMS324 who met any of the following criteria. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab treatment. a) Did not wish to receive alemtuzumab; b) Ongoing participation in any other investigational study, unless approved by Genzyme; c) Had received alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies); d) Known bleeding disorder or therapeutic anticoagulation; e) Diagnosis of idiopathic thrombocytopenia purpura or other autoimmune hematologic abnormality; f) History of malignancy, except basal cell skin carcinoma; g) Intolerance of pulsed corticosteroids, especially a history of steroid psychosis h) Significant Autoimmune disorder (other than MS); i) Major psychiatric disorder or epileptic seizures not adequately controlled by treatment; j) Active infection or high risk for infection k) Unwilling to use a reliable and acceptable contraceptive method during and for at least 6 months following each alemtuzumab treatment cycle (fertile participants only).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Previously treated with alemtuzumab; Alemtuzumab 12 mg per day administered through IV, once a day for 3 consecutive days (participants might receive additional cycles of alemtuzumab upon documented evidence of resumed disease activity, but not within same 12-month period)	Biological: alemtuzumab; Alemtuzumab 12 mg/day IV infusion on 5 consecutive days if the participants had no prior alemtuzumab exposure (ie, first treatment course). All subsequent treatment courses were for 3 days only.
Experimental: Previously treated with interferon beta-1a (Rebif®); Alemtuzumab 12 mg per day administered through IV, once a day for 5 consecutive days during the first cycle and 12 mg per day administered through IV, once a day for 3 consecutive days during the second cycle, 12 months later. Participants might qualify for as-needed retreatment (12 mg per day administered through IV, once a day for 3 consecutive days) after their second fixed annual cycle.	Biological: alemtuzumab; Alemtuzumab 12 mg/day IV infusion on 5 consecutive days if the participants had no prior alemtuzumab exposure (ie, first treatment course). All subsequent treatment courses were for 3 days only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Relapse Rate (ARR)	Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (MS) that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation.	Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively)
Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab	Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through repeated negative binomial regression with robust variance estimation and covariate adjustment for geographic region. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.	Baseline (Year 0 of initial studies) up to Year 4
Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment	Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation without covariate adjustment.	Year 1 prior to retreatment, Year 1, 2, 3 after retreatment
Number of Participants With Sustained Accumulation of Disability (SAD)	SAD: defined as an increase of at least 1.5 points in Expanded Disability Status Scale (EDSS) score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. 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) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD was estimated by Kaplan-Meier method and reported in this outcome measure. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension" group and "alemtuzumab Treatment CAMMS324 Extension" group, respectively.	Baseline (Year 0) up to Year 6
Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison	SAD: defined as an increase of at least 1.5 points in EDSS score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. 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) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD over 2 years before and 2 years after alemtuzumab treatment were estimated by Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.	Baseline (Year 0 of initial studies) up to Year 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6	SRD was defined as a ≥1 point decrease in EDSS score lasting >= 6 months. SRD is only applicable to participants with a baseline EDSS score of >= 2.0. 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 ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 6 was estimated using Kaplan-Meier method and reported in this outcome measure.	Baseline (Year 0) up to Year 6
Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study	SRD was defined as a >=1 point decrease in EDSS score lasting >=6 months. SRD is only applicable to participants with a baseline EDSS score of ≥2.0. 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 ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 2 of CAMMS03409 was estimated using Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.	Extension study (CAMMS03409) baseline up to Extension Year 2
Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6	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), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 [NCT00530348] or CAMMS324 [NCT00548405]) value from EDSS scores at specified time points.	Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6
Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison	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), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 or CAMMS324 for pre alemtuzumab period or CAMMS03409 baseline for post alemtuzumab period) value, from EDSS scores at specified time points. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting groups. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323 participants" and "CAMMS324 participants" respectively.	Baseline (Year 0 of initial studies) up to Year 4
Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment	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), where higher scores indicate worse neurological function. Change was calculated by subtracting retreatment baseline (annual visit prior to the retreatment start date) value from EDSS scores at specified time points.	Retreatment baseline, Year 1, 2 and 3 after retreatment baseline
Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity	Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually.	Year 3, 4, 5 and 6
Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment	Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.	Baseline (Year 0 of initial studies) up to Year 4
Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment	Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. Retreatment baseline was the annual visit prior to the retreatment start date.	Retreatment Baseline, Year 1, 2 and 3 after retreatment
Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6	Lesion volume was quantitatively assessed by hyperintensity on T2-weighted MRI scans.	Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6
Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity	Analysis of new gadolinium-enhancing lesions that appear on MRI scans performed annually. Baseline was the prior annual visit.	Year 3, 4, 5 and 6
Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6	Brain parenchymal fraction (calculated as the ratio of brain parenchymal volume to total intradural volume), is a sensitive indicator of brain atrophy.	Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6
Percentage of Relapse Free Participants	Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability.	Year 3, 4, 5 and 6
Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6	SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.	Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension group", "alemtuzumab Treatment CAMMS324 Extension" group, respectively),Year 3, 4, 5 and 6
Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison	SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323" and "CAMMS324" participants, respectively.	Baseline (Year 0 of initial studies) up to Year 4
Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6	SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.	Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6
Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison	SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323" and "CAMMS324" participants, respectively.	Baseline (Year 0 of initial studies) up to Year 4
Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score at Year 3, 4, 5 and 6	FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life.	Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6
Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score Before and After Alemtuzumab Treatment: 2 Year Comparison	FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.	Baseline (Year 0 of initial studies) up to Year 4
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6	EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement.	Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison	EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and VAS. The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.	Baseline (Year 0 of initial studies) up to Year 4

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• Gilmore W, Lund BT, Li P, Levy AM, Kelland EE, Akbari O, Groshen S, Cen SY, Pelletier D, Weiner LP, Javed A, Dunn JE, Traboulsee AL. Repopulation of T, B, and NK cells following alemtuzumab treatment in relapsing-remitting multiple sclerosis. J Neuroinflammation. 2020 Jun 15;17(1):189. doi: 10.1186/s12974-020-01847-9.
• 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.
• Arroyo R, Bury DP, Guo JD, Margolin DH, Melanson M, Daizadeh N, Cella D. Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis. Mult Scler. 2020 Jul;26(8):955-963. doi: 10.1177/1352458519849796. Epub 2019 May 30.
• 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.
• 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. doi: 10.1056/NEJMoa0802670.
• Bass AD, Arroyo R, Boster AL, Boyko AN, Eichau S, Ionete C, Limmroth V, Navas C, Pelletier D, Pozzilli C, Ravenscroft J, Sousa L, Tintore M, Uitdehaag BMJ, Baker DP, Daizadeh N, Choudhry Z, Rog D; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. Mult Scler Relat Disord. 2021 Apr;49:102717. doi: 10.1016/j.msard.2020.102717. Epub 2020 Dec 24.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: June 26, 2009
• First Submitted That Met QC Criteria: June 26, 2009
• First Posted (Estimate): June 30, 2009

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

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; Antineoplastic Agents; Antineoplastic Agents, Immunological; Alemtuzumab
• Other Study ID Numbers: CAMMS03409; 2009-010788-18 (EudraCT Number); LTE12824 (Other Identifier: Sanofi)