Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00930553
Registration number
NCT00930553
Ethics application status
Date submitted
26/06/2009
Date registered
30/06/2009
Date last updated
15/05/2017
Titles & IDs
Public title
An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Query!
Scientific title
An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Query!
Secondary ID [1]
0
0
2009-010788-18
Query!
Secondary ID [2]
0
0
CAMMS03409
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - alemtuzumab
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)
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.
Other interventions: 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.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Annualized Relapse Rate (ARR)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
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)
Query!
Primary outcome [2]
0
0
Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline (Year 0 of initial studies) up to Year 4
Query!
Primary outcome [3]
0
0
Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Year 1 prior to retreatment, Year 1, 2, 3 after retreatment
Query!
Primary outcome [4]
0
0
Number of Participants With Sustained Accumulation of Disability (SAD)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline (Year 0) up to Year 6
Query!
Primary outcome [5]
0
0
Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline (Year 0 of initial studies) up to Year 4
Query!
Secondary outcome [1]
0
0
Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline (Year 0) up to Year 6
Query!
Secondary outcome [2]
0
0
Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Extension study (CAMMS03409) baseline up to Extension Year 2
Query!
Secondary outcome [3]
0
0
Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
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
Query!
Secondary outcome [4]
0
0
Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline (Year 0 of initial studies) up to Year 4
Query!
Secondary outcome [5]
0
0
Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Retreatment baseline, Year 1, 2 and 3 after retreatment baseline
Query!
Secondary outcome [6]
0
0
Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity
Query!
Assessment method [6]
0
0
Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually.
Query!
Timepoint [6]
0
0
Year 3, 4, 5 and 6
Query!
Secondary outcome [7]
0
0
Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline (Year 0 of initial studies) up to Year 4
Query!
Secondary outcome [8]
0
0
Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Retreatment Baseline, Year 1, 2 and 3 after retreatment
Query!
Secondary outcome [9]
0
0
Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6
Query!
Assessment method [9]
0
0
Lesion volume was quantitatively assessed by hyperintensity on T2-weighted MRI scans.
Query!
Timepoint [9]
0
0
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
Query!
Secondary outcome [10]
0
0
Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity
Query!
Assessment method [10]
0
0
Analysis of new gadolinium-enhancing lesions that appear on MRI scans performed annually. Baseline was the prior annual visit.
Query!
Timepoint [10]
0
0
Year 3, 4, 5 and 6
Query!
Secondary outcome [11]
0
0
Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6
Query!
Assessment method [11]
0
0
Brain parenchymal fraction (calculated as the ratio of brain parenchymal volume to total intradural volume), is a sensitive indicator of brain atrophy.
Query!
Timepoint [11]
0
0
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
Query!
Secondary outcome [12]
0
0
Percentage of Relapse Free Participants
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Year 3, 4, 5 and 6
Query!
Secondary outcome [13]
0
0
Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
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
Query!
Secondary outcome [14]
0
0
Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Baseline (Year 0 of initial studies) up to Year 4
Query!
Secondary outcome [15]
0
0
Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
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
Query!
Secondary outcome [16]
0
0
Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
Baseline (Year 0 of initial studies) up to Year 4
Query!
Secondary outcome [17]
0
0
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
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
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
Query!
Secondary outcome [18]
0
0
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
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
Baseline (Year 0 of initial studies) up to Year 4
Query!
Secondary outcome [19]
0
0
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
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
Query!
Secondary outcome [20]
0
0
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison
Query!
Assessment method [20]
0
0
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.
Query!
Timepoint [20]
0
0
Baseline (Year 0 of initial studies) up to Year 4
Query!
Eligibility
Key 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.
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1314
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Concord Repatriation General Hospital - Concord
Query!
Recruitment hospital [2]
0
0
Southern Neurology - Kogarah
Query!
Recruitment hospital [3]
0
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [4]
0
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [5]
0
0
Gold Coast Hospital - Southport
Query!
Recruitment hospital [6]
0
0
Royal Hobart Hospital - Hobart
Query!
Recruitment hospital [7]
0
0
St. Vincent's Hospital - Fitzroy
Query!
Recruitment hospital [8]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [9]
0
0
Royal Melbourne Hospital - Parkville
Query!
Recruitment hospital [10]
0
0
The Wesley Research Institute - Auchenflower QLD
Query!
Recruitment hospital [11]
0
0
The Queen Elizabeth Hospital - Woodville, SA
Query!
Recruitment postcode(s) [1]
0
0
- Concord
Query!
Recruitment postcode(s) [2]
0
0
- Kogarah
Query!
Recruitment postcode(s) [3]
0
0
- Liverpool
Query!
Recruitment postcode(s) [4]
0
0
- Westmead
Query!
Recruitment postcode(s) [5]
0
0
- Southport
Query!
Recruitment postcode(s) [6]
0
0
- Hobart
Query!
Recruitment postcode(s) [7]
0
0
- Fitzroy
Query!
Recruitment postcode(s) [8]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [9]
0
0
- Parkville
Query!
Recruitment postcode(s) [10]
0
0
- Auchenflower QLD
Query!
Recruitment postcode(s) [11]
0
0
- Woodville, SA
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
District of Columbia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kentucky
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nevada
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Hampshire
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New Jersey
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New Mexico
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New York
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
North Carolina
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Ohio
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Oklahoma
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Pennsylvania
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Rhode Island
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Tennessee
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Texas
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Virginia
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Washington
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Buenos Aires
Query!
Country [33]
0
0
Austria
Query!
State/province [33]
0
0
Vienna
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Brussel
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Esneux
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Leuven
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Porto Alegre
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Recife, PE
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
São Paulo, SP
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
São Paulo,SP
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Alberta
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Ontario
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Quebec
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
London, ON
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Ottawa, Ontario
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Vancouver, BC
Query!
Country [47]
0
0
Croatia
Query!
State/province [47]
0
0
Osijek
Query!
Country [48]
0
0
Croatia
Query!
State/province [48]
0
0
Rijeka
Query!
Country [49]
0
0
Croatia
Query!
State/province [49]
0
0
Varazdin
Query!
Country [50]
0
0
Croatia
Query!
State/province [50]
0
0
Zagreb
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Brno
Query!
Country [52]
0
0
Czechia
Query!
State/province [52]
0
0
Hradec Kralove
Query!
Country [53]
0
0
Czechia
Query!
State/province [53]
0
0
Prague
Query!
Country [54]
0
0
Czechia
Query!
State/province [54]
0
0
Teplice
Query!
Country [55]
0
0
Denmark
Query!
State/province [55]
0
0
Copenhagen
Query!
Country [56]
0
0
Denmark
Query!
State/province [56]
0
0
Århus C
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Dijon Cedex
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Paris Cedex 13
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Rennes Cedex 9
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Strasbourg Cedex
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Toulouse Cedex 9
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
DE
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Berlin-Mitte
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Dresden
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Frankfurt am Main
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Hamburg
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Hannover
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Hennigsdorf
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Ingolstadt
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
München
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Rostock
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Ulm
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Wermsdorf
Query!
Country [74]
0
0
Israel
Query!
State/province [74]
0
0
Ein Karem, Jerusalem
Query!
Country [75]
0
0
Israel
Query!
State/province [75]
0
0
Ramat Gan
Query!
Country [76]
0
0
Israel
Query!
State/province [76]
0
0
Tel Aviv
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Cagliari
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Gallarate (Varese)
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Orbassano (TO)
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Roma
Query!
Country [81]
0
0
Mexico
Query!
State/province [81]
0
0
Chihuahua, CHH
Query!
Country [82]
0
0
Mexico
Query!
State/province [82]
0
0
Mexico City, DFE
Query!
Country [83]
0
0
Netherlands
Query!
State/province [83]
0
0
Den Bosch
Query!
Country [84]
0
0
Netherlands
Query!
State/province [84]
0
0
Sittard-Geleen
Query!
Country [85]
0
0
Poland
Query!
State/province [85]
0
0
Krakow
Query!
Country [86]
0
0
Poland
Query!
State/province [86]
0
0
Lodz
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Lublin
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Poznan
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Warsaw
Query!
Country [90]
0
0
Russian Federation
Query!
State/province [90]
0
0
Kazan
Query!
Country [91]
0
0
Russian Federation
Query!
State/province [91]
0
0
Moscow
Query!
Country [92]
0
0
Russian Federation
Query!
State/province [92]
0
0
Nizhny Novgorod
Query!
Country [93]
0
0
Russian Federation
Query!
State/province [93]
0
0
Novosibirsk
Query!
Country [94]
0
0
Russian Federation
Query!
State/province [94]
0
0
Pyatigorsk
Query!
Country [95]
0
0
Russian Federation
Query!
State/province [95]
0
0
Samara
Query!
Country [96]
0
0
Russian Federation
Query!
State/province [96]
0
0
St. Petersburg
Query!
Country [97]
0
0
Russian Federation
Query!
State/province [97]
0
0
Ufa
Query!
Country [98]
0
0
Serbia
Query!
State/province [98]
0
0
Belgrade
Query!
Country [99]
0
0
Serbia
Query!
State/province [99]
0
0
Kragujevac
Query!
Country [100]
0
0
Serbia
Query!
State/province [100]
0
0
Nis
Query!
Country [101]
0
0
Serbia
Query!
State/province [101]
0
0
Novi Sad
Query!
Country [102]
0
0
Spain
Query!
State/province [102]
0
0
Barcelona
Query!
Country [103]
0
0
Spain
Query!
State/province [103]
0
0
Madrid
Query!
Country [104]
0
0
Spain
Query!
State/province [104]
0
0
Málaga
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Seville
Query!
Country [106]
0
0
Sweden
Query!
State/province [106]
0
0
Göteborg
Query!
Country [107]
0
0
Sweden
Query!
State/province [107]
0
0
Umeå
Query!
Country [108]
0
0
Ukraine
Query!
State/province [108]
0
0
Kharkov
Query!
Country [109]
0
0
Ukraine
Query!
State/province [109]
0
0
Kiev-21
Query!
Country [110]
0
0
Ukraine
Query!
State/province [110]
0
0
Kiev
Query!
Country [111]
0
0
Ukraine
Query!
State/province [111]
0
0
Lviv
Query!
Country [112]
0
0
United Kingdom
Query!
State/province [112]
0
0
Bristol
Query!
Country [113]
0
0
United Kingdom
Query!
State/province [113]
0
0
Cambridge
Query!
Country [114]
0
0
United Kingdom
Query!
State/province [114]
0
0
Cardiff
Query!
Country [115]
0
0
United Kingdom
Query!
State/province [115]
0
0
London
Query!
Country [116]
0
0
United Kingdom
Query!
State/province [116]
0
0
Salford
Query!
Country [117]
0
0
United Kingdom
Query!
State/province [117]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Genzyme, a Sanofi Company
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Bayer
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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:
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00930553
Query!
Trial related presentations / publications
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.
Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Fisher E, Brinar VV, Giovannoni G, Stojanovic M, Ertik BI, Lake SL, Margolin DH, Panzara MA, Compston DA; CARE-MS I investigators. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1819-28. doi: 10.1016/S0140-6736(12)61769-3. Epub 2012 Nov 1.
Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DA; CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1829-39. doi: 10.1016/S0140-6736(12)61768-1. Epub 2012 Nov 1.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Monitor
Query!
Address
0
0
Genzyme Coorporation
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00930553
Download to PDF