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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00930553
First received: June 26, 2009
Last updated: May 2, 2017
Last verified: May 2017
  Purpose

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.

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting Biological: alemtuzumab Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • Annualized Relapse Rate (ARR) [ Time Frame: 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) ]
    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.

  • Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]
    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.

  • Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment [ Time Frame: Year 1 prior to retreatment, Year 1, 2, 3 after 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.

  • Number of Participants With Sustained Accumulation of Disability (SAD) [ Time Frame: Baseline (Year 0) up to Year 6 ]
    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.

  • Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6 [ Time Frame: Baseline (Year 0) up to 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.

  • Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study [ Time Frame: Extension study (CAMMS03409) baseline up to Extension Year 2 ]
    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.

  • Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6 [ Time Frame: 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 ]
    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.

  • Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]
    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.

  • Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment [ Time Frame: Retreatment baseline, Year 1, 2 and 3 after retreatment baseline ]
    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.

  • Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity [ Time Frame: Year 3, 4, 5 and 6 ]
    Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually.

  • Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]
    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.

  • Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment [ Time Frame: Retreatment Baseline, Year 1, 2 and 3 after 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.

  • Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6 [ Time Frame: 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 ]
    Lesion volume was quantitatively assessed by hyperintensity on T2-weighted MRI scans.

  • Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity [ Time Frame: Year 3, 4, 5 and 6 ]
    Analysis of new gadolinium-enhancing lesions that appear on MRI scans performed annually. Baseline was the prior annual visit.

  • Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6 [ Time Frame: 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 ]
    Brain parenchymal fraction (calculated as the ratio of brain parenchymal volume to total intradural volume), is a sensitive indicator of brain atrophy.

  • Percentage of Relapse Free Participants [ Time Frame: Year 3, 4, 5 and 6 ]
    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.

  • Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6 [ Time Frame: 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 ]
    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.

  • Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]
    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.

  • Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6 [ Time Frame: 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 ]
    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.

  • Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]
    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.

  • 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 [ Time Frame: 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 ]
    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.

  • 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 [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]
    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.

  • Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6 [ Time Frame: 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 ]
    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.

  • Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison [ Time Frame: Baseline (Year 0 of initial studies) up to Year 4 ]
    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.


Enrollment: 1314
Study Start Date: August 2009
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930553

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

Publications:
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00930553     History of Changes
Other Study ID Numbers: CAMMS03409
2009-010788-18 ( EudraCT Number )
LTE12824 ( Other Identifier: Sanofi )
Study First Received: June 26, 2009
Results First Received: February 16, 2017
Last Updated: May 2, 2017

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Alemtuzumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 17, 2017