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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alemtuzumab
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 - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Given written/signed informed consent
  • Age 18 to 50 years old (inclusive) as of the date the informed consent form (ICF) was signed
  • Diagnosis of MS per updated McDonald criteria, and cranial magnetic resonance imaging (MRI) scan demonstrating white matter lesions attributable to MS within 5 years of screening
  • Onset of MS symptoms (as determined by a neurologist, either at screening or retrospectively) within 5 years of the date the ICF was signed
  • Expanded Disability Status Scale (EDSS) score 0.0 to 3.0 (inclusive) at screening
  • Greater than or equal to (>=) 2 MS attacks (first episode or relapse) occurring in the 24 months prior to the date the ICF was signed, with >=1 attack in the 12 months prior to the date the ICF was signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other Genzyme-approved health-care provider and the objective signs could be identified retrospectively

Exclusion Criteria:

  • Received prior therapy for MS other than corticosteroids, for example, alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, and mitoxantrone
  • Exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, or any other immunosuppressive agent other than systemic corticosteroid treatment
  • Any progressive form of MS
  • History of malignancy (except basal skin cell carcinoma)
  • CD4 + , CD8 + count, B cell, or absolute neutrophil count less than (<) lower limit of normal (LLN) at screening
  • Known bleeding disorder (for example, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, or clotting factor deficiency)
  • Significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
  • Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (that is, above the LLN)
  • Active infection or at high risk for infection

Sites / Locations

  • North Central Neurology Associates, P.C.
  • Barrow Neurological Institute, St. Joseph's Hospital & Medical Center
  • Mayo Clinic Arizona
  • Northwest NeuroSpecialists, PLLC
  • Advanced Neurosciences Research
  • Neurological Associates
  • Axiom Clinical Research of Florida
  • Idaho Falls Multiple Sclerosis Center, PLLC
  • Consultants in Neurology, Ltd.
  • Fort Wayne Neurological Center
  • University of Kansas Medical Center
  • MidAmerican Neuroscience Institute
  • Associates in Neurology, PSC
  • University of Louisville Research Foundation
  • Louisiana State University Health Sciences Center
  • UMass Memorial Medical Center
  • University of Michigan Health System
  • Wayne State University
  • University of Nevada School of Medicine
  • Dartmouth-Hitchcock Medical Center
  • University of New Mexico, Health Sciences Center, MS Specialty Clinic
  • Empire Neurology
  • Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.
  • University of Rochester Medical Center
  • Carolinas Medical Center (CMC), Neurosciences & Spine Institute (NSSI)
  • The Ohio State University Medical Center, Multiple Sclerosis Center
  • Oak Clinic for Multiple Sclerosis
  • MS Center of Oklahoma
  • Lehigh Valley Hospital Neurosciences and Pain Research
  • Advanced Neurosciences Institute
  • Biomedical Research Alliance of NY, LLC
  • Hope Neurology PC
  • Baylor College of Medicine, Maxine Mesinger MS Clinic
  • Central Texas Neurology
  • Integra Clinical Research
  • Neurology Center of San Antonio
  • DIABAID
  • The Wesley Research Institute
  • Griffith University School of Medicine
  • The Queen Elizabeth Hospital
  • Royal Hobart Hospital
  • St Vincent's Hospital
  • Austin Health
  • Royal Melbourne Hospital, Department of Neurology, Ward 4 East
  • Concord Repatriation General Hospital
  • Westmead Hospital
  • Hospital da Restauracao, Av Governador Agamenon Magalhaes
  • Hospital Sao Lucas PUC-RS
  • Hospital de Clínicas USP
  • University of Calgary and Foothills Medical Cenre
  • UBC Hospital
  • The Ottawa Hospital, General Campus
  • Clinique Nuero-outaouais
  • Clinique Neuro rive-sud, Recherche Sepmus, Inc.
  • Clinical Hospital Centre Rijeka
  • General Hospital Varazdin
  • Clinical Hospital Centre "Sestre Milosrdnice"
  • Clinical Hospital Centre Zagreb
  • General Hospital "Sveti Duh"
  • Department of Neurology, 1st Faculty of Medicine and General Teaching Hospital
  • Krajska zdravotni a.s., Hospital Teplice
  • Hopital Purpan
  • Judisches Krankenhaus Berlin
  • Universitätsklinik Carl Gustav Carus Dresden
  • Klinikum der Goethe Universität Frankfurt
  • Medizinische Hochschule Hannover
  • Oberhavelkliniken Hennigsdorf
  • Asklepios Klinikum Brandenburg
  • Hospital Angeles del Pedregal, Camino de Santa Teresa
  • Hospital Medica Sur CIF-BIOTEC
  • Clinical Neurology Centre Sp. z o.o. (Ltd)
  • 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
  • Moscow City Hospital #11
  • Moscow State Medical Institution City Clinical Hospital #11
  • Scientific Neurology Center RAMS
  • Municipal City Hospital #33
  • Federal State Institution Siberian Rettitorial Medical Center under Federal Medical-Biological Agency of Russia
  • City Clinical Hospital #2
  • Samara Regional Clinical Hospital n.a. Kalinin
  • Institute of Human Brain RAS
  • Nikolaevskaya Hospital
  • St. Petersburg Pavlov State Medical University
  • State Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov
  • Clinical Centre Serbia, Institute for Neurology
  • Military Medical Academy
  • Clinical centre Kragujevac
  • Clinical Center Nis, Clinic for neurology
  • Clinical Centre of Vojvodina, Clinic for neurology
  • Sahlgrenska University Hospital
  • Chernihiv Regional Hospital
  • Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine, Department of Neuroinfection and Multiple Sclerosis
  • Hospoital of the Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Department
  • Kyiv Municipal Clinical Hospital #4
  • Danylo Halytsky Lviv National Medical University
  • 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
  • University Hospital of Wales
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alemtuzumab

Interferon Beta-1a

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Accumulation of Disability (SAD)
EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least next 2 scheduled assessments, that is, 6 consecutive months. Onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.
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 quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.
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
September 13, 2007
Last Updated
November 17, 2014
Sponsor
Genzyme, a Sanofi Company
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00530348
Brief Title
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One
Acronym
CARE-MS I
Official Title
A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 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 alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.
Detailed Description
Every participant had received active treatment; there was no placebo. Participants who qualified were randomly assigned to treatment with either alemtuzumab or SC interferon beta-1a at a 2:1 ratio (that is, 2 given alemtuzumab for every 1 given interferon beta-1a). Alemtuzumab was administered in two annual courses, once at the beginning of the study and again 1 year later. Interferon beta-1a was self-injected 3 times per week for 2 years. All participants were required to return to their study site every 3 months for neurologic assessment. In addition, safety-related laboratory tests were performed at least monthly. Participation in this study ended 2 years after the start of treatment for each participant. Additionally, participants who received alemtuzumab might be followed in CAMMS03409 (NCT00930553) an extension study for safety and efficacy assessments. Participants who received interferon beta-1a and completed 2 years on study might be eligible to receive alemtuzumab on the extension study.

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
581 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alemtuzumab
Arm Type
Experimental
Arm Title
Interferon Beta-1a
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Alemtuzumab
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)
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 quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least next 2 scheduled assessments, that is, 6 consecutive months. Onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.
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 quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.
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
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Given written/signed informed consent Age 18 to 50 years old (inclusive) as of the date the informed consent form (ICF) was signed Diagnosis of MS per updated McDonald criteria, and cranial magnetic resonance imaging (MRI) scan demonstrating white matter lesions attributable to MS within 5 years of screening Onset of MS symptoms (as determined by a neurologist, either at screening or retrospectively) within 5 years of the date the ICF was signed Expanded Disability Status Scale (EDSS) score 0.0 to 3.0 (inclusive) at screening Greater than or equal to (>=) 2 MS attacks (first episode or relapse) occurring in the 24 months prior to the date the ICF was signed, with >=1 attack in the 12 months prior to the date the ICF was signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other Genzyme-approved health-care provider and the objective signs could be identified retrospectively Exclusion Criteria: Received prior therapy for MS other than corticosteroids, for example, alemtuzumab, interferons, intravenous immunoglobulin, glatiramer acetate, natalizumab, and mitoxantrone Exposure to azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, or any other immunosuppressive agent other than systemic corticosteroid treatment Any progressive form of MS History of malignancy (except basal skin cell carcinoma) CD4 + , CD8 + count, B cell, or absolute neutrophil count less than (<) lower limit of normal (LLN) at screening Known bleeding disorder (for example, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, or clotting factor deficiency) Significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (that is, above the LLN) Active infection or at high risk for infection
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 & Medical Center
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Northwest NeuroSpecialists, PLLC
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Advanced Neurosciences Research
City
Fort Collins
State/Province
Colorado
Country
United States
Facility Name
Neurological Associates
City
Pompano Beach
State/Province
Florida
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Idaho Falls Multiple Sclerosis Center, PLLC
City
Idaho Falls
State/Province
Idaho
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
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
MidAmerican 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
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
University of Nevada School of Medicine
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
University of New Mexico, Health Sciences Center, MS Specialty Clinic
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Empire Neurology
City
Latham
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
Carolinas Medical Center (CMC), Neurosciences & Spine Institute (NSSI)
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
The Ohio State University Medical Center, Multiple Sclerosis Center
City
Columbus
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 Neurosciences and Pain Research
City
Allentown
State/Province
Pennsylvania
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
Baylor College of Medicine, Maxine Mesinger MS Clinic
City
Houston
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
DIABAID
City
Buenos Aires
Country
Argentina
Facility Name
The Wesley Research Institute
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Griffith University School of Medicine
City
Southport
State/Province
Queensland
Country
Australia
Facility Name
The Queen Elizabeth Hospital
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
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Royal Melbourne Hospital, Department of Neurology, Ward 4 East
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
Country
Australia
Facility Name
Hospital da Restauracao, Av Governador Agamenon Magalhaes
City
Recife
State/Province
Pernambuco
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
State/Province
SP
Country
Brazil
Facility Name
University of Calgary and Foothills Medical Cenre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
UBC Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
The Ottawa Hospital, General Campus
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Clinique Nuero-outaouais
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
Clinical Hospital Centre Rijeka
City
Rijeka
Country
Croatia
Facility Name
General Hospital Varazdin
City
Varazdin
Country
Croatia
Facility Name
Clinical Hospital Centre "Sestre Milosrdnice"
City
Zagreb
Country
Croatia
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
Country
Croatia
Facility Name
General Hospital "Sveti Duh"
City
Zagreb
Country
Croatia
Facility Name
Department of Neurology, 1st Faculty of Medicine and General Teaching Hospital
City
Praha 2
Country
Czech Republic
Facility Name
Krajska zdravotni a.s., Hospital Teplice
City
Teplice
Country
Czech Republic
Facility Name
Hopital Purpan
City
Toulouse
Country
France
Facility Name
Judisches Krankenhaus Berlin
City
Berlin
Country
Germany
Facility Name
Universitätsklinik Carl Gustav Carus Dresden
City
Dresden
Country
Germany
Facility Name
Klinikum der Goethe Universität Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Oberhavelkliniken Hennigsdorf
City
Hennigsdorf
Country
Germany
Facility Name
Asklepios Klinikum Brandenburg
City
Teupitz
Country
Germany
Facility Name
Hospital Angeles del Pedregal, Camino de Santa Teresa
City
Mexico City
Country
Mexico
Facility Name
Hospital Medica Sur CIF-BIOTEC
City
Mexico City
Country
Mexico
Facility Name
Clinical Neurology Centre Sp. z o.o. (Ltd)
City
Cracow
Country
Poland
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
Moscow City Hospital #11
City
Moscow
Country
Russian Federation
Facility Name
Moscow State Medical Institution City Clinical Hospital #11
City
Moscow
Country
Russian Federation
Facility Name
Scientific Neurology Center RAMS
City
Moscow
Country
Russian Federation
Facility Name
Municipal City Hospital #33
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Federal State Institution Siberian Rettitorial Medical Center under Federal Medical-Biological Agency of Russia
City
Novosibirsk
Country
Russian Federation
Facility Name
City Clinical Hospital #2
City
Pyatigorsk
Country
Russian Federation
Facility Name
Samara Regional Clinical Hospital n.a. Kalinin
City
Samara
Country
Russian Federation
Facility Name
Institute of Human Brain RAS
City
St. Petersburg
Country
Russian Federation
Facility Name
Nikolaevskaya Hospital
City
St. Petersburg
Country
Russian Federation
Facility Name
St. Petersburg Pavlov State Medical University
City
St. Petersburg
Country
Russian Federation
Facility Name
State Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov
City
Ufa
Country
Russian Federation
Facility Name
Clinical Centre Serbia, Institute for Neurology
City
Belgrade
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
Country
Serbia
Facility Name
Clinical centre Kragujevac
City
Kragujevac
Country
Serbia
Facility Name
Clinical Center Nis, Clinic for neurology
City
Nis
Country
Serbia
Facility Name
Clinical Centre of Vojvodina, Clinic for neurology
City
Novi Sad
Country
Serbia
Facility Name
Sahlgrenska University Hospital
City
Goteborg
Country
Sweden
Facility Name
Chernihiv Regional Hospital
City
Chernihiv
Country
Ukraine
Facility Name
Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine, Department of Neuroinfection and Multiple Sclerosis
City
Kharkiv
Country
Ukraine
Facility Name
Hospoital of the Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Department
City
Kyiv
Country
Ukraine
Facility Name
Kyiv Municipal Clinical Hospital #4
City
Kyiv
Country
Ukraine
Facility Name
Danylo Halytsky Lviv National Medical University
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
University Hospital of Wales
City
Cardiff
State/Province
Wales
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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Coles AJ, Arnold DL, Bass AD, Boster AL, Compston DAS, Fernandez O, Havrdova EK, Nakamura K, Traboulsee A, Ziemssen T, Jacobs A, Margolin DH, Huang X, Daizadeh N, Chirieac MC, Selmaj KW. Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial. Ther Adv Neurol Disord. 2021 Apr 23;14:1756286420982134. doi: 10.1177/1756286420982134. eCollection 2021.
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PubMed Identifier
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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.
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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.
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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 One

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