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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alemtuzumab 12 mg
Alemtuzumab 24 mg
Interferon beta-1a
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Central Neurology Associates, P.C.
  • Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
  • Hope Research Institute
  • Mayo Clinic Arizona, Department of Neurology
  • Northwest NeuroSpecialists, PLLC
  • East Bay Physicians Medical Group/Sutter East Bay Medical Foundation
  • Neurology Center of North Orange County
  • Department of Neurology, Keck School of Medicine, University of Southern California
  • Neuro-Therapeutics Inc.
  • Neuro-Therapeutics, Inc
  • University of California, Davis Medical Center
  • Stanford University School of Medicine
  • University of Colorado Hospital, Anschutz Outpatient Pavilioin
  • Neurological Consultants
  • Advanced Neurosciences Research
  • Yale University
  • George Washington University Medical Faculty Associates
  • University of Florida Neuroscience Institute
  • Neurology Associates, P.A.
  • Neurological Associates
  • Negroski, Stein, Sutherland and Hanes Neurology
  • Axiom Clinical Research of Florida
  • University of South Florida, Department of Neurology
  • Emory University, Department of Neurology
  • Shepherd Center, Inc.
  • Idaho Falls Multiple Sclerosis Center, PLLC
  • University of Chicago Medical Center, Department of Neurology
  • Consultants in Neurology, Ltd
  • Fort Wayne Neurological Center
  • Indiana University School of Medicine, Department of Neurology
  • Josephson Wallack Munshower Neurology P.C.
  • Iowa Health Physicians
  • Ruan Neurology Clinic and Research Center
  • University of Kansas Medical Center, Department of Neurology
  • MidAmerica Neuroscience Institute
  • Associates in Neurology, PSC
  • University of Louisville Research Foundation
  • Louisiana State University Health Sciences Center
  • Caritas St. Elizabeth's Medical Center
  • Partners Multiple Sclerosis Center/Brigham and Women's Hospital
  • Springfield Neurology Associates, LLC
  • UMass Memorial Medical Center
  • University of Michigan Department of Neurology
  • Henry Ford Hospital
  • Wayne State University, School of Medicine, Department of Neurology
  • Spectrum Health Medical Group, Neurology (Previously known as Michigan Medical P.C., Neurology)
  • Michigan Neurology Associates, P.C.
  • Northern Michigan Neurology
  • Mayo Clinic Rochester
  • Neurology Consultants of Kansas City, Inc.
  • Montana Neurobehavioral Specialists
  • University of Nevada School of Medicine
  • Renown Institute for Neurosciences / Renown regional Medical Center
  • Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center
  • MS Center at Holy Name Hospital
  • University of New Mexico, Health Sciences Center, MS Specialty Clinic
  • Empire Neurology, PC
  • Winthrop University Hospital, Clinical Trials Center
  • Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis
  • Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.
  • University of Rochester Medical Center
  • SUNY Upstate Medical University, Department of Neurology
  • University of North Carolina-Chapel Hill, Department of Neurology
  • Wake Forest University Health Science, Department of Neurology
  • Cleveland Clinic Foundation, Mellen Center
  • Neurology Specialists, Inc.
  • Oak Clinic for Multiple Sclerosis
  • MS Center of Oklahoma
  • Lehigh Valley Hospital, Neuroscience and Pain Research
  • Northshore Clinical Associates
  • University of Pittsburgh, Kaufmann Medical Building
  • The Neurology Foundation, Inc.
  • Neurology Clinic, P.C.
  • Advanced Neurosciences Institute
  • Biomedical Research Alliance of NY, LLC
  • Hope Neurology PC
  • Vanderbilt Multiple Sclerosis Center
  • Clinical Center for Multiple Sclerosis
  • Central Texas Neurology
  • Integra Clinical Research
  • Neurology Center of San Antonio
  • MS Center of Greater Washington, P.C.
  • Swedish Neuroscience Institute
  • Virginia Mason Medical Center
  • Rockwood Clinical Research Center
  • DIABAID
  • Westmead Hospital
  • The Wesley Research Institute
  • Griffith School of Medicine, Gold Coast Campus, Griffith University
  • Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department
  • Royal Hobart Hospital
  • St. Vincent's Hospital, MS Education & Research, Department of Clinical Neurosciences
  • Austin Health
  • Royal Melbourne Hospital, Department of Neurology
  • Concord Repatriation General Hospital, Neurosciences Department
  • Southern Neurology
  • Liverpool Hospital, Neurology Department
  • AKH Wien, Universitätsklinikum für Neurologie
  • Cliniques Universitaires Saint-Luc, Neurology
  • CHU Ourthe Amblève, Neurology
  • University Hospital Leuven, Campus Gasthuisberg, Neurology
  • Hospital da Restauracao
  • Hospital Sao Lucas PUC-RS
  • Hospital de Clínicas USP
  • Irmandade da Santa Casa de Misericordia de Sao Paulo
  • UBC Hospital
  • Multiple Sclerosis Clinic, Connell 7, Kingston General Hospital
  • London Health Sciences Centre- University Hospital
  • The Ottawa Hospital, General Campus
  • Sunnybrook Health Sciences Centre
  • Centre de Sante et de Services Sociaux de Gatineau-Hull Hospital
  • Clinique Neuro rive-sud, Recherche sepmus inc
  • Hospital Maisonneuve-Rosemont
  • Montreal Neurological Institute and Hospital
  • Clinical Hospital Centre Rijeka, Clinic for Neurology
  • General Hospital Varazdin, Department of neurology
  • Clinical Hospital Centre Zagreb
  • Clinical Hospital Sestre Milosrdnice
  • General Hospital " Sveti Duh", Department of neurology
  • MS Center, Department of Neurology
  • St. Anne's University Hospital Brno
  • Department of Neurology 1st Faculty of Medicine and General Teaching Hospital, MS Center
  • Krajska zdravotni a.s. - Hospital Teplice
  • Århus Universitetshospital, Scleroseklinikken, Århus Sygehus
  • Scleroseklinikken, Rigshospitalet
  • Odense University Hospital
  • CHU Clermont-Ferrand, Hôpital Gabriel Montpied
  • Hôpital General, Service de Neurologie
  • Hospital Roger Salengro
  • Hôpital Pitié Salpétrière, Service de Neurologie
  • Sevice de Neurologie
  • Hôpital Civil, Departement de Neurologie
  • Krankenhaus Hohe Warte, Betriebsstätte der Bayreuth
  • Judisches Krankenhaus Berlin
  • Neurologisches Fachzentrum Berlin
  • Neurologische Universitätsklinik Bonn
  • Multiple Sklerose Zentrum am, Zentrum für klinische Neurowissenschaften, Neurologische Uniklinik Dresden
  • Asklepios Klinic Barmbek
  • Medizinische Hochshule Hannover
  • Oberhavelkliniken Hennigsdorf
  • Klinikum Ingolstadt, Neurologische Klinik
  • Klinikum Rechts der Isar, Klinik für Neurologie
  • Klinik und Poliklinik fur Neurologie der Universitat Rockstock
  • Universitatsklinik Ulm
  • Fachkrankenhaus Hubertusburg
  • Hadassah Medical Center Ein Karem
  • Tel Aviv Sourasky Medical Center, Department of Neurology
  • Sheba Medical Centre
  • Ospedale Binaghi - Centro Sclerosi Multipla
  • Ospedale S. Antonio Abate di Gallarate
  • Università di Genova Dipartimento di Neuroscienze Oftalmologia e Genetica
  • Ospedale Civile di Brescia c/o Ospedale Richiedei, Centro di riferimento per la Sclerosi Multiple
  • Ospedale San Luigi di Orbassano
  • Azienda Ospedaliera Sant'Andrea Neurologia
  • Hospital Medica Sur CIF-BIOTEC
  • Unidad de Investigación en Salud de Chihuahua, S.C.
  • Hospital Angeles del Pedregal; Camino a Santa Teresa
  • Jeroen Bosch Ziekenhuis
  • Orbis Medisch Centrum, Department of Neurology
  • Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz
  • Independent Public Teaching Hospital No. 4 in Lublin
  • Heliodor Swiecicki Teaching Hospital of the Poznan, University of Medical Sciences
  • Research Medical Complex "Your Health" Ltd
  • Institution of the Russian Academy of Medical Sciences, "Neurology Scientific Center under RAMS"
  • Moscow State Medical Institution City Clinical Hospital #11, Moscow City Center for Multiple Sclerosis
  • Moscow State Public Medical Institution, City Clinical Hospital #11
  • Municipal Treatment and Prevention Institution, "City Hospital #33"
  • Federal State Institution: Siberian District Medical Center
  • State Medical Institution, "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
  • Institution of the Russian Academy of Sciences, "Institute of the Human Brain n.a. N.P. Bekhtereva within the Russian Academy of Sciences"
  • St. Petersburg Pavlov State Medical University, Department of Neurology and Neurosurgery with a Clinic
  • St.Petersburg State Medical Institution, "City Multispecialty Hospital #2"
  • St.Petersburg State Medical Institution, "Nikolayevskaya Hospital"
  • Clinic of Neurology, Clinical Centre of Serbia
  • Military Medical Academy
  • Clinical Centre of Kragujevac
  • Clinical Centre Vojvodina Institute of Neurology
  • Servicio de Neurología Hospital Vall d'Hebron Paseo de Vall d'Hebron
  • Servicio de Neurología Hospital Clínico San Carlos
  • Servicio de Neurología Hospital Carlos Haya
  • Servicio de Neurología Hospital Virgen de la Macarena
  • Sahlgrenska University Hospital, Neurologkliniken
  • Norrlands Universitets sjukhus
  • Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine
  • Kyiv Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System
  • Danylo Halytsky Lviv National Medical University, Department of Neurology
  • Department Of Neurosciences, Addenbrookes Hospital
  • Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science Barts and The London School of Medicine and Dentistry
  • Frenchay Hospital
  • Salford Royal NHS Foundation Trust, Clinical Trials Unit
  • Department of Neurology Glossop Road, Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Alemtuzumab 12 mg

Alemtuzumab 24 mg

Interferon Beta-1a

Arm Description

Alemtuzumab (Lemtrada™) 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.

Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.

Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Accumulation of Disability (SAD)
EDSS is an ordinal scale in half-point increments that qualifies 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 the next 2 scheduled assessments, that is, 6 consecutive months. The 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.
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.

Secondary Outcome Measures

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.
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (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.
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.
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).

Full Information

First Posted
October 22, 2007
Last Updated
March 17, 2017
Sponsor
Genzyme, a Sanofi Company
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00548405
Brief Title
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
Acronym
CARE-MS II
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
840 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alemtuzumab 12 mg
Arm Type
Experimental
Arm Description
Alemtuzumab (Lemtrada™) 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.
Arm Title
Alemtuzumab 24 mg
Arm Type
Experimental
Arm Description
Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
Arm Title
Interferon Beta-1a
Arm Type
Active Comparator
Arm Description
Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Intervention Type
Biological
Intervention Name(s)
Alemtuzumab 12 mg
Other Intervention Name(s)
Lemtrada
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Alemtuzumab 24 mg
Other Intervention Name(s)
Lemtrada
Intervention Description
Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
Intervention Type
Biological
Intervention Name(s)
Interferon beta-1a
Other Intervention Name(s)
Rebif®
Intervention Description
Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Accumulation of Disability (SAD)
Description
EDSS is an ordinal scale in half-point increments that qualifies 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 the next 2 scheduled assessments, that is, 6 consecutive months. The 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.
Time Frame
Up to 2 years
Title
Annualized Relapse Rate
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Were Relapse Free at Year 2
Description
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.
Time Frame
Year 2
Title
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2
Description
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (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.
Time Frame
Baseline, Year 2
Title
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2
Description
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.
Time Frame
Baseline, Year 2
Title
Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2
Description
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).
Time Frame
Baseline, Year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
North Central Neurology Associates, P.C.
City
Cullman
State/Province
Alabama
Country
United States
Facility Name
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Mayo Clinic Arizona, Department of Neurology
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Northwest NeuroSpecialists, PLLC
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
East Bay Physicians Medical Group/Sutter East Bay Medical Foundation
City
Berkeley
State/Province
California
Country
United States
Facility Name
Neurology Center of North Orange County
City
La Habra
State/Province
California
Country
United States
Facility Name
Department of Neurology, Keck School of Medicine, University of Southern California
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Neuro-Therapeutics Inc.
City
Pasadena
State/Province
California
Country
United States
Facility Name
Neuro-Therapeutics, Inc
City
Pasadena
State/Province
California
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
Country
United States
Facility Name
University of Colorado Hospital, Anschutz Outpatient Pavilioin
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Neurological Consultants
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Advanced Neurosciences Research
City
Fort Collins
State/Province
Colorado
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
University of Florida Neuroscience Institute
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Neurology Associates, P.A.
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Neurological Associates
City
Pompano Beach
State/Province
Florida
Country
United States
Facility Name
Negroski, Stein, Sutherland and Hanes Neurology
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
Country
United States
Facility Name
University of South Florida, Department of Neurology
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Emory University, Department of Neurology
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Shepherd Center, Inc.
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Idaho Falls Multiple Sclerosis Center, PLLC
City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
University of Chicago Medical Center, Department of Neurology
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Consultants in Neurology, Ltd
City
Northbrook
State/Province
Illinois
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
Indiana University School of Medicine, Department of Neurology
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Josephson Wallack Munshower Neurology P.C.
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Iowa Health Physicians
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
Ruan Neurology Clinic and Research Center
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
University of Kansas Medical Center, Department of Neurology
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
MidAmerica Neuroscience Institute
City
Lenexa
State/Province
Kansas
Country
United States
Facility Name
Associates in Neurology, PSC
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
University of Louisville Research Foundation
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Caritas St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Partners Multiple Sclerosis Center/Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Springfield Neurology Associates, LLC
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan Department of Neurology
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Wayne State University, School of Medicine, Department of Neurology
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Spectrum Health Medical Group, Neurology (Previously known as Michigan Medical P.C., Neurology)
City
Grand Rapids
State/Province
Michigan
Country
United States
Facility Name
Michigan Neurology Associates, P.C.
City
St. Clair Shores
State/Province
Michigan
Country
United States
Facility Name
Northern Michigan Neurology
City
Traverse City
State/Province
Michigan
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Neurology Consultants of Kansas City, Inc.
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Montana Neurobehavioral Specialists
City
Missoula
State/Province
Montana
Country
United States
Facility Name
University of Nevada School of Medicine
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Renown Institute for Neurosciences / Renown regional Medical Center
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
MS Center at Holy Name Hospital
City
Teaneck
State/Province
New Jersey
Country
United States
Facility Name
University of New Mexico, Health Sciences Center, MS Specialty Clinic
City
Alburquerque
State/Province
New Mexico
Country
United States
Facility Name
Empire Neurology, PC
City
Latham
State/Province
New York
Country
United States
Facility Name
Winthrop University Hospital, Clinical Trials Center
City
Mineola
State/Province
New York
Country
United States
Facility Name
Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis
City
New York
State/Province
New York
Country
United States
Facility Name
Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.
City
Patchogue
State/Province
New York
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
Country
United States
Facility Name
SUNY Upstate Medical University, Department of Neurology
City
Syracuse
State/Province
New York
Country
United States
Facility Name
University of North Carolina-Chapel Hill, Department of Neurology
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Wake Forest University Health Science, Department of Neurology
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Cleveland Clinic Foundation, Mellen Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Neurology Specialists, Inc.
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Oak Clinic for Multiple Sclerosis
City
Uniontown
State/Province
Ohio
Country
United States
Facility Name
MS Center of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Lehigh Valley Hospital, Neuroscience and Pain Research
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Northshore Clinical Associates
City
Erie
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh, Kaufmann Medical Building
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
The Neurology Foundation, Inc.
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
Neurology Clinic, P.C.
City
Cordova
State/Province
Tennessee
Country
United States
Facility Name
Advanced Neurosciences Institute
City
Franklin
State/Province
Tennessee
Country
United States
Facility Name
Biomedical Research Alliance of NY, LLC
City
Franklin
State/Province
Tennessee
Country
United States
Facility Name
Hope Neurology PC
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Vanderbilt Multiple Sclerosis Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Clinical Center for Multiple Sclerosis
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Central Texas Neurology
City
Round Rock
State/Province
Texas
Country
United States
Facility Name
Integra Clinical Research
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Neurology Center of San Antonio
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
MS Center of Greater Washington, P.C.
City
Vienna
State/Province
Virginia
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Rockwood Clinical Research Center
City
Spokane
State/Province
Washington
Country
United States
Facility Name
DIABAID
City
Buenos Aires
Country
Argentina
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
The Wesley Research Institute
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Griffith School of Medicine, Gold Coast Campus, Griffith University
City
Southport
State/Province
Queensland
Country
Australia
Facility Name
Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department
City
Woodville South
State/Province
South Australia
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
St. Vincent's Hospital, MS Education & Research, Department of Clinical Neurosciences
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Royal Melbourne Hospital, Department of Neurology
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Concord Repatriation General Hospital, Neurosciences Department
City
Concord
Country
Australia
Facility Name
Southern Neurology
City
Kogarah
Country
Australia
Facility Name
Liverpool Hospital, Neurology Department
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Facility Name
AKH Wien, Universitätsklinikum für Neurologie
City
Wien
Country
Austria
Facility Name
Cliniques Universitaires Saint-Luc, Neurology
City
Brussel
Country
Belgium
Facility Name
CHU Ourthe Amblève, Neurology
City
Esneux
Country
Belgium
Facility Name
University Hospital Leuven, Campus Gasthuisberg, Neurology
City
Leuven
Country
Belgium
Facility Name
Hospital da Restauracao
City
Recife
State/Province
PE
Country
Brazil
Facility Name
Hospital Sao Lucas PUC-RS
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Hospital de Clínicas USP
City
Sao Paulo
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericordia de Sao Paulo
City
Sao Paulo
Country
Brazil
Facility Name
UBC Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Multiple Sclerosis Clinic, Connell 7, Kingston General Hospital
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre- University Hospital
City
London
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital, General Campus
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Centre de Sante et de Services Sociaux de Gatineau-Hull Hospital
City
Gatineau
State/Province
Quebec
Country
Canada
Facility Name
Clinique Neuro rive-sud, Recherche sepmus inc
City
Greenfield park
State/Province
Quebec
Country
Canada
Facility Name
Hospital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Clinical Hospital Centre Rijeka, Clinic for Neurology
City
Rijeka
Country
Croatia
Facility Name
General Hospital Varazdin, Department of neurology
City
Varazdin
Country
Croatia
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
Country
Croatia
Facility Name
Clinical Hospital Sestre Milosrdnice
City
Zagreb
Country
Croatia
Facility Name
General Hospital " Sveti Duh", Department of neurology
City
Zagreb
Country
Croatia
Facility Name
MS Center, Department of Neurology
City
Hradec Kralove
Country
Czech Republic
Facility Name
St. Anne's University Hospital Brno
City
Pekarska
Country
Czech Republic
Facility Name
Department of Neurology 1st Faculty of Medicine and General Teaching Hospital, MS Center
City
Praha 2
Country
Czech Republic
Facility Name
Krajska zdravotni a.s. - Hospital Teplice
City
Teplice
Country
Czech Republic
Facility Name
Århus Universitetshospital, Scleroseklinikken, Århus Sygehus
City
Aarhus
Country
Denmark
Facility Name
Scleroseklinikken, Rigshospitalet
City
København
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
CHU Clermont-Ferrand, Hôpital Gabriel Montpied
City
Clermont-Ferrand
Country
France
Facility Name
Hôpital General, Service de Neurologie
City
Dijon Cedex
Country
France
Facility Name
Hospital Roger Salengro
City
Lille Cedex
Country
France
Facility Name
Hôpital Pitié Salpétrière, Service de Neurologie
City
Paris
Country
France
Facility Name
Sevice de Neurologie
City
Rennes Cedex
Country
France
Facility Name
Hôpital Civil, Departement de Neurologie
City
Strasbourg Cedex
Country
France
Facility Name
Krankenhaus Hohe Warte, Betriebsstätte der Bayreuth
City
Bayreuth
Country
Germany
Facility Name
Judisches Krankenhaus Berlin
City
Berlin
Country
Germany
Facility Name
Neurologisches Fachzentrum Berlin
City
Berlin
Country
Germany
Facility Name
Neurologische Universitätsklinik Bonn
City
Bonn
Country
Germany
Facility Name
Multiple Sklerose Zentrum am, Zentrum für klinische Neurowissenschaften, Neurologische Uniklinik Dresden
City
Dresden
Country
Germany
Facility Name
Asklepios Klinic Barmbek
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochshule Hannover
City
Hannover
Country
Germany
Facility Name
Oberhavelkliniken Hennigsdorf
City
Hennigsdorf
Country
Germany
Facility Name
Klinikum Ingolstadt, Neurologische Klinik
City
Ingolstadt
Country
Germany
Facility Name
Klinikum Rechts der Isar, Klinik für Neurologie
City
Muenchen
Country
Germany
Facility Name
Klinik und Poliklinik fur Neurologie der Universitat Rockstock
City
Rostock
Country
Germany
Facility Name
Universitatsklinik Ulm
City
Ulm
Country
Germany
Facility Name
Fachkrankenhaus Hubertusburg
City
Wermsdorf
Country
Germany
Facility Name
Hadassah Medical Center Ein Karem
City
Jerusalem
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center, Department of Neurology
City
Tel Aviv
Country
Israel
Facility Name
Sheba Medical Centre
City
Tel Hashomer
Country
Israel
Facility Name
Ospedale Binaghi - Centro Sclerosi Multipla
City
Cagliari
Country
Italy
Facility Name
Ospedale S. Antonio Abate di Gallarate
City
Gallarate
Country
Italy
Facility Name
Università di Genova Dipartimento di Neuroscienze Oftalmologia e Genetica
City
Genova
Country
Italy
Facility Name
Ospedale Civile di Brescia c/o Ospedale Richiedei, Centro di riferimento per la Sclerosi Multiple
City
Montichiari
Country
Italy
Facility Name
Ospedale San Luigi di Orbassano
City
Orbassano
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea Neurologia
City
Roma
Country
Italy
Facility Name
Hospital Medica Sur CIF-BIOTEC
City
Delegacion
State/Province
Tlalpan
Country
Mexico
Facility Name
Unidad de Investigación en Salud de Chihuahua, S.C.
City
Chihuahua
Country
Mexico
Facility Name
Hospital Angeles del Pedregal; Camino a Santa Teresa
City
Mexico City
Country
Mexico
Facility Name
Jeroen Bosch Ziekenhuis
City
Hertogenbosch
Country
Netherlands
Facility Name
Orbis Medisch Centrum, Department of Neurology
City
Sittard
Country
Netherlands
Facility Name
Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz
City
Lodz
Country
Poland
Facility Name
Independent Public Teaching Hospital No. 4 in Lublin
City
Lublin
Country
Poland
Facility Name
Heliodor Swiecicki Teaching Hospital of the Poznan, University of Medical Sciences
City
Poznan
Country
Poland
Facility Name
Research Medical Complex "Your Health" Ltd
City
Kazan
Country
Russian Federation
Facility Name
Institution of the Russian Academy of Medical Sciences, "Neurology Scientific Center under RAMS"
City
Moscow
Country
Russian Federation
Facility Name
Moscow State Medical Institution City Clinical Hospital #11, Moscow City Center for Multiple Sclerosis
City
Moscow
Country
Russian Federation
Facility Name
Moscow State Public Medical Institution, City Clinical Hospital #11
City
Moscow
Country
Russian Federation
Facility Name
Municipal Treatment and Prevention Institution, "City Hospital #33"
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Federal State Institution: Siberian District Medical Center
City
Novosibirsk
Country
Russian Federation
Facility Name
State Medical Institution, "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
City
Samara
Country
Russian Federation
Facility Name
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 Name
St. Petersburg Pavlov State Medical University, Department of Neurology and Neurosurgery with a Clinic
City
St. Petersburg
Country
Russian Federation
Facility Name
St.Petersburg State Medical Institution, "City Multispecialty Hospital #2"
City
St. Petersburg
Country
Russian Federation
Facility Name
St.Petersburg State Medical Institution, "Nikolayevskaya Hospital"
City
St. Petersburg
Country
Russian Federation
Facility Name
Clinic of Neurology, Clinical Centre of Serbia
City
Belgrade
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
Country
Serbia
Facility Name
Clinical Centre of Kragujevac
City
Kragujevac
Country
Serbia
Facility Name
Clinical Centre Vojvodina Institute of Neurology
City
Novi Sad
Country
Serbia
Facility Name
Servicio de Neurología Hospital Vall d'Hebron Paseo de Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Servicio de Neurología Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Servicio de Neurología Hospital Carlos Haya
City
Malaga
Country
Spain
Facility Name
Servicio de Neurología Hospital Virgen de la Macarena
City
Sevilla
Country
Spain
Facility Name
Sahlgrenska University Hospital, Neurologkliniken
City
Gothenburg
Country
Sweden
Facility Name
Norrlands Universitets sjukhus
City
Umea
Country
Sweden
Facility Name
Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine
City
Kharkov
Country
Ukraine
Facility Name
Kyiv Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System
City
Kyiv
Country
Ukraine
Facility Name
Danylo Halytsky Lviv National Medical University, Department of Neurology
City
Lviv
Country
Ukraine
Facility Name
Department Of Neurosciences, Addenbrookes Hospital
City
Cambridge
State/Province
England
Country
United Kingdom
Facility Name
Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science Barts and The London School of Medicine and Dentistry
City
London
State/Province
England
Country
United Kingdom
Facility Name
Frenchay Hospital
City
Bristol
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust, Clinical Trials Unit
City
Salford
Country
United Kingdom
Facility Name
Department of Neurology Glossop Road, Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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Citation
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Links:
URL
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003718/WC500150521.pdf
Description
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003718/WC500150521.pdf

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Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two

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