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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

alemtuzumab

About this trial

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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

North Central Neurology Associates, P.C.
HOPE Research Institute
St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute
Mayo Clinic Arizona (Scottsdale)
Northwest NeuroSpecialists, PLLC
East Bay Physicians Medical Group/ Sutter East Bay Medical Foundation
Neurology Center North Orange County
University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center
Neuro-Therapeutics, Inc.
Stanford University Medical Center
University of Colorado Health Science Center - Aurora
Advanced Neurology of Colorado
Yale MS Research Center
The 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 College of Medicine
Emory University Department of Neurology
Shepherd Center Multiple Sclerosis Institute
University of Chicago Medical Center
Consultants in Neurology, LTD
Fort Wayne Neurological Center
Indiana University Multiple Sclerosis Center
Iowa Health Physicians
Ruan Neurology Clinic and Clinical Research Center, Mercy Medical Center
University of Kansas Medical Center, Department of Neurology
MidAmerica Neuroscience Institute
Associates in Neurology, P.S.C.
Kentucky Neuroscience Research
University of Maryland, Maryland Center for MS
The MS Center at St. Elizabeth's
UMass Memorial Medical Center
University of Michigan Medical School
Michigan Neurology Association
Wayne State University, The School of Medicine, Department of Neurology
Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS Clinic
Northern Michigan Neurology
Saint Luke's Brain & Stroke Institute
Renown Institute for Neurosciences
Dartmouth Hitchcock Medical Center
MS Center at Holy Name Hospital
University of New Mexico, Dept. of Neurology
Empire Neurology P.C.
Winthrop University Hospital Multiple Sclerosis Treatment Center
MS Care Center at NYUMC and HJD
The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
South Shore Neurologic Associates, P.C.
Rochester Multiple Sclerosis Center
SUNY Upstate Medical University, Department of Neurology
The University of North Carolina at Chapel Hill
Wake Forest University Health Science Department of Neurology
Cleveland Clinic Foundation
Oak Clinic for Multiple Sclerosis
OMRF Multiple Sclerosis Center of Excellence
Lehigh Valley Hospital Neurosciences and Pain Research
Rhode Island Hospital MS Center - The Neurology Foundation, Inc
Neurology Clinic PC
Advanced Neurosciences Institute
Hope Neurology
Vanderbilt University Medical Center
Baylor College of Medicine, Maxine Mesinger MS Clinic
Central Texas Neurology Consultants
Integra Clinical Research
Neurology Center of San Antonio
MS Center of Greater Washington
Swedish Medical MS Center
DIABAID
Concord Repatriation General Hospital
Southern Neurology
Liverpool Hospital
Westmead Hospital
Gold Coast Hospital
Royal Hobart Hospital
St. Vincent's Hospital
Austin Health
Royal Melbourne Hospital
The Wesley Research Institute
The Queen Elizabeth Hospital
AKH Wien-Universitätskliniken für Neurologie
Cliniques Universitaires Saint-luc
CHU Ourthe Amblève
University Hospital Leuven, Campus Gasthuisberg
Hospital Mae de Deus
Hospital da Restauração, Neurology department
Irmandade da Santa Casa de Misericórdio de São Paulo, Neurology department
Hospital das Clínicas da Faculdade de Medicina da USP, Neurology department
University of Calgary, Department of Neurology
Kingston General Hospital MS Clinic
Clinique Neuro-Outaouais
Recherche Sepmus, Inc.
Hopital Maisonneuve-Rosemont
London Health Sciences Centre - University Hospital
The Ottawa Hospital - MS Research
University of British Columbia
Clinical Hospital Osijek
Clinical Hospital Centre Rijeka
General Hospital Varazdin, Department for Neurology
Clinical Hospital Centre "Sestre Milosrdnice"
Clinical Hospital Centre Zagreb
Clinical Hospital Sveti Duh
St. Anne's University Hospital Brno
University Hospital Hradec Králové
General Hospital, 128 21 Praha 2
Hospital Teplice, Neurology Department, MS centrum
Rigshospitalet Department of Neurology
Aarhus Sygehus
Hôpital Général
Groupe Hospitalier Pitié-Salpêtrière, Fédération de Maladies du System Nerveux Central
CHU Pontchaillou
Hôpital Civil
CHU de Toulouse, Hôpital Purpan
Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn
Jüdisches Krankenhaus Berlin
Universitätsklinik Carl Gustav Carus Dresden
Klinikum der JW Goethe Universität
Asklepios Klinik Barmbek
Medizinische Hochschule Hannover
Oberhavel Klinicum GmbH - Krankenhaus Hennigsdorf
Klinikum Ingolstadt
Klinikum rechts der Isar
Medizinische Fakultät der Universität Rostock,Zentrum für Nervenheilkunde
Universitätsklinikum Ulm, Klinik für Neurologie im RKU
Fachkrankenhaus Hubertusburg GmbH, Klinik für Neurologie und Neurologische Intensivmedizin
Hadassah Medical Center Ein Karem
Sheba Medical Center
Sourasky Tel Aviv Medical Center
Università di Cagliari
Ospedale S. Antonio Abate di Gallarate
Ospedale S. Luigi Gonzaga
Universita Degli Studi di Roma "La Sapienza"
Unidad de Investigación en Salud
Medica Sur
Jeroen Bosch Ziekenhuis
Orbis Medisch Concern
Centrum Neurologii Klinicznej Sp. Zo.o.
Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny Nr1 im. Norberta Barlickiego
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Med. im. Karola Marcinkowskiego w Poznaniu
Institute of Psychiatry and Neurology/Instytut Psychiatrii i Neurologii
Research Medical Complex "Your Health" Ltd
Moscow State Public Medical Institution Clinical Hospital #11, Neurology Department
Neurology Research Center under the Russian Academy of Medical Sciences
Russian State Medical University, Department of Neurology and Neurosurgery
Municipal Treatment and Prevention Institution, City Hospital #33
Federal State Public Medical Institution: Siberian District Medical Center under the Federal Agency
Municipal Public Medical Institution: City Hospital #2 of Pyatigorsk, Neurology Department
Samara Regional Clinical Hospital n.a. Kalinin
Institute of Human Brain RAS, Laboratory of Neuroimmunology
St Petersburg State Pavlov Medical University, Dept of Neurology and Neurosurgery with a Hospital
St. Petersburg General Hospital #2, Neurology Department #2
St. Petersburg State Public Medical Institution: Nikolayevskaya Hospital
State Public Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov
Clinical Centre Serbia, Institute of Neurology,Dr.Subotica 6,Belgrade
Military Medical Academy, Institute of Neurology
Clinical Centre Kragujevac, Clinic of Neurology
Clinical Centre Nis, Clinic of Neurology
Clinical Centre Vojvodina
Hospital Universitario Vall d' Hebron
Hospital Clínico Universitario San Carlos
Hospital Carlos Haya, Neurology Service
Hospital Virgen Macarena
SU/Östra sjukhuset
Norrlands Universitets sjukhus
Institute of Neurology, Psychiatry and Narcology under the AMS of Ukraine, Dep of Neuroinfection& MS
Hospital of Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Dept.
Kiev Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System
Lviv National Medical University n.a. Danylo Galytsky, Department of Neurology
Frenchay Hospital
Addenbrookes Hospital
University Hospital of Wales, Dept of Neurology
Royal London Hospital
Salford Royal NHS Foundation Trust
Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Previously treated with alemtuzumab

Previously treated with interferon beta-1a (Rebif®)

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Annualized Relapse Rate (ARR)

Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (MS) that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation.

Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab

Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through repeated negative binomial regression with robust variance estimation and covariate adjustment for geographic region. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.

Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment

Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation without covariate adjustment.

Number of Participants With Sustained Accumulation of Disability (SAD)

SAD: defined as an increase of at least 1.5 points in Expanded Disability Status Scale (EDSS) score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD was estimated by Kaplan-Meier method and reported in this outcome measure. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension" group and "alemtuzumab Treatment CAMMS324 Extension" group, respectively.

Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison

SAD: defined as an increase of at least 1.5 points in EDSS score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD over 2 years before and 2 years after alemtuzumab treatment were estimated by Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.

Secondary Outcome Measures

Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6

SRD was defined as a ≥1 point decrease in EDSS score lasting >= 6 months. SRD is only applicable to participants with a baseline EDSS score of >= 2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 6 was estimated using Kaplan-Meier method and reported in this outcome measure.

Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study

SRD was defined as a >=1 point decrease in EDSS score lasting >=6 months. SRD is only applicable to participants with a baseline EDSS score of ≥2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 2 of CAMMS03409 was estimated using Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.

Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6

Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison

EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 or CAMMS324 for pre alemtuzumab period or CAMMS03409 baseline for post alemtuzumab period) value, from EDSS scores at specified time points. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting groups. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323 participants" and "CAMMS324 participants" respectively.

Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment

Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity

Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually.

Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment

Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.

Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment

Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. Retreatment baseline was the annual visit prior to the retreatment start date.

Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6

Lesion volume was quantitatively assessed by hyperintensity on T2-weighted MRI scans.

Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity

Analysis of new gadolinium-enhancing lesions that appear on MRI scans performed annually. Baseline was the prior annual visit.

Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6

Brain parenchymal fraction (calculated as the ratio of brain parenchymal volume to total intradural volume), is a sensitive indicator of brain atrophy.

Percentage of Relapse Free Participants

Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6

Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison

SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323" and "CAMMS324" participants, respectively.

Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6

Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison

SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323" and "CAMMS324" participants, respectively.

Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score at Year 3, 4, 5 and 6

FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life.

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

Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6

EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement.

Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison

EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and VAS. The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.

Full Information

NCT ID

NCT00930553

First Posted

June 26, 2009

Last Updated

May 2, 2017

Sponsor

Genzyme, a Sanofi Company

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00930553

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (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

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: 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. 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. 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.

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.

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

Non-Randomized

Enrollment

1314 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Previously treated with alemtuzumab

Arm Type

Experimental

Arm Description

Arm Title

Previously treated with interferon beta-1a (Rebif®)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

alemtuzumab

Intervention Description

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.

Primary Outcome Measure Information:

Title

Annualized Relapse Rate (ARR)

Description

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)

Title

Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab

Description

Time Frame

Baseline (Year 0 of initial studies) up to Year 4

Title

Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment

Description

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.

Time Frame

Year 1 prior to retreatment, Year 1, 2, 3 after retreatment

Title

Number of Participants With Sustained Accumulation of Disability (SAD)

Description

Time Frame

Baseline (Year 0) up to Year 6

Title

Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison

Description

Time Frame

Baseline (Year 0 of initial studies) up to Year 4

Secondary Outcome Measure Information:

Title

Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6

Description

Time Frame

Baseline (Year 0) up to Year 6

Title

Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study

Description

Time Frame

Extension study (CAMMS03409) baseline up to Extension Year 2

Title

Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6

Description

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

Title

Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison

Description

Time Frame

Baseline (Year 0 of initial studies) up to Year 4

Title

Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment

Description

Time Frame

Retreatment baseline, Year 1, 2 and 3 after retreatment baseline

Title

Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity

Description

Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually.

Time Frame

Year 3, 4, 5 and 6

Title

Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment

Description

Time Frame

Baseline (Year 0 of initial studies) up to Year 4

Title

Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment

Description

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.

Time Frame

Retreatment Baseline, Year 1, 2 and 3 after retreatment

Title

Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6

Description

Lesion volume was quantitatively assessed by hyperintensity on T2-weighted MRI scans.

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

Title

Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity

Description

Analysis of new gadolinium-enhancing lesions that appear on MRI scans performed annually. Baseline was the prior annual visit.

Time Frame

Year 3, 4, 5 and 6

Title

Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6

Description

Brain parenchymal fraction (calculated as the ratio of brain parenchymal volume to total intradural volume), is a sensitive indicator of brain atrophy.

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

Title

Percentage of Relapse Free Participants

Description

Time Frame

Year 3, 4, 5 and 6

Title

Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6

Description

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

Title

Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison

Description

Time Frame

Baseline (Year 0 of initial studies) up to Year 4

Title

Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6

Description

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

Title

Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison

Description

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.

Time Frame

Baseline (Year 0 of initial studies) up to Year 4

Title

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

Description

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

Title

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

Description

Time Frame

Baseline (Year 0 of initial studies) up to Year 4

Title

Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6

Description

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

Title

Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison

Description

Time Frame

Baseline (Year 0 of initial studies) up to Year 4

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Genzyme Coorporation

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

HOPE Research Institute

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

Mayo Clinic Arizona (Scottsdale)

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 North Orange County

City

La Habra

State/Province

California

Country

United States

Facility Name

University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center

City

Los Angeles

State/Province

California

Country

United States

Facility Name

Neuro-Therapeutics, Inc.

City

Pasadena

State/Province

California

Country

United States

Facility Name

Stanford University Medical Center

City

Stanford

State/Province

California

Country

United States

Facility Name

University of Colorado Health Science Center - Aurora

City

Aurora

State/Province

Colorado

Country

United States

Facility Name

Advanced Neurology of Colorado

City

Fort Collins

State/Province

Colorado

Country

United States

Facility Name

Yale MS Research Center

City

New Haven

State/Province

Connecticut

Country

United States

Facility Name

The George Washington University Medical Faculty Associates

City

Washington, D.C.

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 College of Medicine

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 Multiple Sclerosis Institute

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

University of Chicago Medical Center

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 Multiple Sclerosis Center

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 Clinical Research Center, Mercy Medical 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, P.S.C.

City

Lexington

State/Province

Kentucky

Country

United States

Facility Name

Kentucky Neuroscience Research

City

Louisville

State/Province

Kentucky

Country

United States

Facility Name

University of Maryland, Maryland Center for MS

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

The MS Center at St. Elizabeth's

City

Boston

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 Medical School

City

Ann Arbor

State/Province

Michigan

Country

United States

Facility Name

Michigan Neurology Association

City

Clinton

State/Province

Michigan

Country

United States

Facility Name

Wayne State University, The School of Medicine, Department of Neurology

City

Detroit

State/Province

Michigan

Country

United States

Facility Name

Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS Clinic

City

Grand Rapids

State/Province

Michigan

Country

United States

Facility Name

Northern Michigan Neurology

City

Traverse City

State/Province

Michigan

Country

United States

Facility Name

Saint Luke's Brain & Stroke Institute

City

Kansas City

State/Province

Missouri

Country

United States

Facility Name

Renown Institute for Neurosciences

City

Reno

State/Province

Nevada

Country

United States

Facility Name

Dartmouth Hitchcock Medical 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, Dept. of Neurology

City

Albuquerque

State/Province

New Mexico

Country

United States

Facility Name

Empire Neurology P.C.

City

Latham

State/Province

New York

Country

United States

Facility Name

Winthrop University Hospital Multiple Sclerosis Treatment Center

City

Mineola

State/Province

New York

Country

United States

Facility Name

MS Care Center at NYUMC and HJD

City

New York

State/Province

New York

Country

United States

Facility Name

The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai

City

New York

State/Province

New York

Country

United States

Facility Name

South Shore Neurologic Associates, P.C.

City

Patchogue

State/Province

New York

Country

United States

Facility Name

Rochester Multiple Sclerosis 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

The University of North Carolina at Chapel Hill

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

City

Cleveland

State/Province

Ohio

Country

United States

Facility Name

Oak Clinic for Multiple Sclerosis

City

Uniontown

State/Province

Ohio

Country

United States

Facility Name

OMRF Multiple Sclerosis Center of Excellence

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

Rhode Island Hospital MS Center - The Neurology Foundation, Inc

City

Providence

State/Province

Rhode Island

Country

United States

Facility Name

Neurology Clinic PC

City

Cordova

State/Province

Tennessee

Country

United States

Facility Name

Advanced Neurosciences Institute

City

Franklin

State/Province

Tennessee

Country

United States

Facility Name

Hope Neurology

City

Knoxville

State/Province

Tennessee

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

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 Consultants

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

City

Vienna

State/Province

Virginia

Country

United States

Facility Name

Swedish Medical MS Center

City

Seattle

State/Province

Washington

Country

United States

Facility Name

DIABAID

City

Buenos Aires

Country

Argentina

Facility Name

Concord Repatriation General Hospital

City

Concord

State/Province

New South Wales

Country

Australia

Facility Name

Southern Neurology

City

Kogarah

State/Province

New South Wales

Country

Australia

Facility Name

Liverpool Hospital

City

Liverpool

State/Province

New South Wales

Country

Australia

Facility Name

Westmead Hospital

City

Westmead

State/Province

New South Wales

Country

Australia

Facility Name

Gold Coast Hospital

City

Southport

State/Province

Queensland

Country

Australia

Facility Name

Royal Hobart Hospital

City

Hobart

State/Province

Tasmania

Country

Australia

Facility Name

St. Vincent's Hospital

City

Fitzroy

State/Province

Victoria

Country

Australia

Facility Name

Austin Health

City

Heidelberg

State/Province

Victoria

Country

Australia

Facility Name

Royal Melbourne Hospital

City

Parkville

State/Province

Victoria

Country

Australia

Facility Name

The Wesley Research Institute

City

Auchenflower QLD

Country

Australia

Facility Name

The Queen Elizabeth Hospital

City

Woodville, SA

Country

Australia

Facility Name

AKH Wien-Universitätskliniken für Neurologie

City

Vienna

Country

Austria

Facility Name

Cliniques Universitaires Saint-luc

City

Brussel

Country

Belgium

Facility Name

CHU Ourthe Amblève

City

Esneux

Country

Belgium

Facility Name

University Hospital Leuven, Campus Gasthuisberg

City

Leuven

Country

Belgium

Facility Name

Hospital Mae de Deus

City

Porto Alegre

Country

Brazil

Facility Name

Hospital da Restauração, Neurology department

City

Recife, PE

Country

Brazil

Facility Name

Irmandade da Santa Casa de Misericórdio de São Paulo, Neurology department

City

São Paulo, SP

Country

Brazil

Facility Name

Hospital das Clínicas da Faculdade de Medicina da USP, Neurology department

City

São Paulo,SP

Country

Brazil

Facility Name

University of Calgary, Department of Neurology

City

Calgary

State/Province

Alberta

Country

Canada

Facility Name

Kingston General Hospital MS Clinic

City

Kingston

State/Province

Ontario

Country

Canada

Facility Name

Clinique Neuro-Outaouais

City

Gatineau

State/Province

Quebec

Country

Canada

Facility Name

Recherche Sepmus, Inc.

City

Greenfield Park

State/Province

Quebec

Country

Canada

Facility Name

Hopital Maisonneuve-Rosemont

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

London Health Sciences Centre - University Hospital

City

London, ON

Country

Canada

Facility Name

The Ottawa Hospital - MS Research

City

Ottawa, Ontario

Country

Canada

Facility Name

University of British Columbia

City

Vancouver, BC

Country

Canada

Facility Name

Clinical Hospital Osijek

City

Osijek

Country

Croatia

Facility Name

Clinical Hospital Centre Rijeka

City

Rijeka

Country

Croatia

Facility Name

General Hospital Varazdin, Department for Neurology

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

Clinical Hospital Sveti Duh

City

Zagreb

Country

Croatia

Facility Name

St. Anne's University Hospital Brno

City

Brno

Country

Czechia

Facility Name

University Hospital Hradec Králové

City

Hradec Kralove

Country

Czechia

Facility Name

General Hospital, 128 21 Praha 2

City

Prague

Country

Czechia

Facility Name

Hospital Teplice, Neurology Department, MS centrum

City

Teplice

Country

Czechia

Facility Name

Rigshospitalet Department of Neurology

City

Copenhagen

Country

Denmark

Facility Name

Aarhus Sygehus

City

Århus C

Country

Denmark

Facility Name

Hôpital Général

City

Dijon Cedex

Country

France

Facility Name

Groupe Hospitalier Pitié-Salpêtrière, Fédération de Maladies du System Nerveux Central

City

Paris Cedex 13

Country

France

Facility Name

CHU Pontchaillou

City

Rennes Cedex 9

Country

France

Facility Name

Hôpital Civil

City

Strasbourg Cedex

Country

France

Facility Name

CHU de Toulouse, Hôpital Purpan

City

Toulouse Cedex 9

Country

France

Facility Name

Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn

City

Bonn

State/Province

Country

Germany

Facility Name

Jüdisches Krankenhaus Berlin

City

Berlin-Mitte

Country

Germany

Facility Name

Universitätsklinik Carl Gustav Carus Dresden

City

Dresden

Country

Germany

Facility Name

Klinikum der JW Goethe Universität

City

Frankfurt am Main

Country

Germany

Facility Name

Asklepios Klinik Barmbek

City

Hamburg

Country

Germany

Facility Name

Medizinische Hochschule Hannover

City

Hannover

Country

Germany

Facility Name

Oberhavel Klinicum GmbH - Krankenhaus Hennigsdorf

City

Hennigsdorf

Country

Germany

Facility Name

Klinikum Ingolstadt

City

Ingolstadt

Country

Germany

Facility Name

Klinikum rechts der Isar

City

München

Country

Germany

Facility Name

Medizinische Fakultät der Universität Rostock,Zentrum für Nervenheilkunde

City

Rostock

Country

Germany

Facility Name

Universitätsklinikum Ulm, Klinik für Neurologie im RKU

City

Ulm

Country

Germany

Facility Name

Fachkrankenhaus Hubertusburg GmbH, Klinik für Neurologie und Neurologische Intensivmedizin

City

Wermsdorf

Country

Germany

Facility Name

Hadassah Medical Center Ein Karem

City

Ein Karem, Jerusalem

Country

Israel

Facility Name

Sheba Medical Center

City

Ramat Gan

Country

Israel

Facility Name

Sourasky Tel Aviv Medical Center

City

Tel Aviv

Country

Israel

Facility Name

Università di Cagliari

City

Cagliari

Country

Italy

Facility Name

Ospedale S. Antonio Abate di Gallarate

City

Gallarate (Varese)

Country

Italy

Facility Name

Ospedale S. Luigi Gonzaga

City

Orbassano (TO)

Country

Italy

Facility Name

Universita Degli Studi di Roma "La Sapienza"

City

Roma

Country

Italy

Facility Name

Unidad de Investigación en Salud

City

Chihuahua, CHH

Country

Mexico

Facility Name

Medica Sur

City

Mexico City, DFE

Country

Mexico

Facility Name

Jeroen Bosch Ziekenhuis

City

Den Bosch

Country

Netherlands

Facility Name

Orbis Medisch Concern

City

Sittard-Geleen

Country

Netherlands

Facility Name

Centrum Neurologii Klinicznej Sp. Zo.o.

City

Krakow

Country

Poland

Facility Name

Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny Nr1 im. Norberta Barlickiego

City

Lodz

Country

Poland

Facility Name

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

City

Lublin

Country

Poland

Facility Name

Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Med. im. Karola Marcinkowskiego w Poznaniu

City

Poznan

Country

Poland

Facility Name

Institute of Psychiatry and Neurology/Instytut Psychiatrii i Neurologii

City

Warsaw

Country

Poland

Facility Name

Research Medical Complex "Your Health" Ltd

City

Kazan

Country

Russian Federation

Facility Name

Moscow State Public Medical Institution Clinical Hospital #11, Neurology Department

City

Moscow

Country

Russian Federation

Facility Name

Neurology Research Center under the Russian Academy of Medical Sciences

City

Moscow

Country

Russian Federation

Facility Name

Russian State Medical University, Department of Neurology and Neurosurgery

City

Moscow

Country

Russian Federation

Facility Name

Municipal Treatment and Prevention Institution, City Hospital #33

City

Nizhny Novgorod

Country

Russian Federation

Facility Name

Federal State Public Medical Institution: Siberian District Medical Center under the Federal Agency

City

Novosibirsk

Country

Russian Federation

Facility Name

Municipal Public Medical Institution: City Hospital #2 of Pyatigorsk, Neurology Department

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, Laboratory of Neuroimmunology

City

St. Petersburg

Country

Russian Federation

Facility Name

St Petersburg State Pavlov Medical University, Dept of Neurology and Neurosurgery with a Hospital

City

St. Petersburg

Country

Russian Federation

Facility Name

St. Petersburg General Hospital #2, Neurology Department #2

City

St. Petersburg

Country

Russian Federation

Facility Name

St. Petersburg State Public Medical Institution: Nikolayevskaya Hospital

City

St. Petersburg

Country

Russian Federation

Facility Name

State Public Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov

City

Ufa

Country

Russian Federation

Facility Name

Clinical Centre Serbia, Institute of Neurology,Dr.Subotica 6,Belgrade

City

Belgrade

Country

Serbia

Facility Name

Military Medical Academy, Institute of Neurology

City

Belgrade

Country

Serbia

Facility Name

Clinical Centre Kragujevac, Clinic of Neurology

City

Kragujevac

Country

Serbia

Facility Name

Clinical Centre Nis, Clinic of Neurology

City

Nis

Country

Serbia

Facility Name

Clinical Centre Vojvodina

City

Novi Sad

Country

Serbia

Facility Name

Hospital Universitario Vall d' Hebron

City

Barcelona

Country

Spain

Facility Name

Hospital Clínico Universitario San Carlos

City

Madrid

Country

Spain

Facility Name

Hospital Carlos Haya, Neurology Service

City

Málaga

Country

Spain

Facility Name

Hospital Virgen Macarena

City

Seville

Country

Spain

Facility Name

SU/Östra sjukhuset

City

Göteborg

Country

Sweden

Facility Name

Norrlands Universitets sjukhus

City

Umeå

Country

Sweden

Facility Name

Institute of Neurology, Psychiatry and Narcology under the AMS of Ukraine, Dep of Neuroinfection& MS

City

Kharkov

Country

Ukraine

Facility Name

Hospital of Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Dept.

City

Kiev-21

Country

Ukraine

Facility Name

Kiev Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System

City

Kiev

Country

Ukraine

Facility Name

Lviv National Medical University n.a. Danylo Galytsky, Department of Neurology

City

Lviv

Country

Ukraine

Facility Name

Frenchay Hospital

City

Bristol

Country

United Kingdom

Facility Name

Addenbrookes Hospital

City

Cambridge

Country

United Kingdom

Facility Name

University Hospital of Wales, Dept of Neurology

City

Cardiff

Country

United Kingdom

Facility Name

Royal London Hospital

City

London

Country

United Kingdom

Facility Name

Salford Royal NHS Foundation Trust

City

Salford

Country

United Kingdom

Facility Name

Royal Hallamshire Hospital

City

Sheffield

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

18946064

Citation

CAMMS223 Trial Investigators; Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008 Oct 23;359(17):1786-801. doi: 10.1056/NEJMoa0802670.

Results Reference

background

PubMed Identifier

23122652

Citation

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

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