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

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ClinicalTrials.gov Identifier: NCT00930553
Recruitment Status : Completed
First Posted : June 30, 2009
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Sclerosis, Relapsing-Remitting
Intervention Biological: alemtuzumab
Enrollment 1314
Recruitment Details This extension study enrolled participants from previous 3 studies: CAMMS223 (NCT00050778), CAMMS323 (NCT00530348), and CAMMS324 (NCT00548405). Participants were enrolled in this study only after their Month 24 visit in CAMMS323 and CAMMS324. CAMMS223 participants were enrolled within 6 months once their site received approval of extension study.
Pre-assignment Details Efficacy outcome data was analyzed only on CAMMS323 and CAMMS324 participants; safety data was analyzed on all participants, as pre-specified in protocol.
Arm/Group Title Alemtuzumab
Hide Arm/Group Description Participants enrolled from any of the prior studies received long-term follow-up in this study. Participants randomized to receive interferon beta-1a (IFNB-1a) in prior studies received alemtuzumab 12 mg/day infusion intravenously (IV) once daily (QD) for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on magnetic resonance imaging [MRI]), unless they met safety-related retreatment disqualifying criteria.
Period Title: Overall Study
Started 1314
Participants Entered From CAMMS223 141
Participants Entered From CAMMS323 488
Participants Entered From CAMMS324 685
Completed 1091
Not Completed 223
Reason Not Completed
Adverse Event             1
Lack of Efficacy             7
Physician Decision             39
Protocol Violation             1
Pregnancy             1
Withdrawal by Subject             88
Lost to Follow-up             25
Death             9
Study terminated by sponsor             24
Other than specified above             28
Arm/Group Title Alemtuzumab
Hide Arm/Group Description Participants enrolled from any of the previous studies received long-term follow-up in this study. Participants randomized to receive IFNB-1a in any of the previous studies received alemtuzumab 12 mg/day infusion IV, QD for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on MRI), unless they met safety-related retreatment disqualifying criteria.
Overall Number of Baseline Participants 1314
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1314 participants
36.7  (8.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1314 participants
Female
857
  65.2%
Male
457
  34.8%
1.Primary Outcome
Title Annualized Relapse Rate (ARR)
Hide Description Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study (CAMMS03409).
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study (CAMMS03409).
Overall Number of Participants Analyzed 353 391
Measure Type: Number
Unit of Measure: relapses per participant per year
Year 3 0.19 0.22
Year 4 0.16 0.24
Year 5 0.15 0.19
Year 6 0.12 0.16
2.Primary Outcome
Title Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab
Hide 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 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.
Time Frame Baseline (Year 0 of initial studies) up to Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.
Arm/Group Title IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)
Hide Arm/Group Description:
Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Overall Number of Participants Analyzed 139 139 143 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: relapses per participant per year
0.42
(0.28 to 0.64)
0.14
(0.09 to 0.21)
0.60
(0.45 to 0.78)
0.15
(0.10 to 0.22)
3.Primary Outcome
Title Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.
Arm/Group Title Alemtuzumab Retreatment
Hide Arm/Group Description:
Participants who received alemtuzumab in CAMMS323 (NCT00530348) or CAMMS324 (NCT00548405), received an additional course of alemtuzumab in this study.
Overall Number of Participants Analyzed 321
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: relapses per participant per year
Year 1 prior to retreatment
0.79
(0.73 to 0.87)
Year 1 after retreatment
0.18
(0.14 to 0.24)
Year 2 after retreatment
0.29
(0.23 to 0.38)
Year 3 after retreatment
0.30
(0.21 to 0.41)
4.Primary Outcome
Title Number of Participants With Sustained Accumulation of Disability (SAD)
Hide Description 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.
Time Frame Baseline (Year 0) up to Year 6
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study.
Overall Number of Participants Analyzed 376 426
Measure Type: Count of Participants
Unit of Measure: Participants
79 118
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alemtuzumab Treatment CAMMS323 Extension
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with SAD
Estimated Value 22.33
Confidence Interval (2-Sided) 95%
18.33 to 27.06
Estimation Comments The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alemtuzumab Treatment CAMMS324 Extension
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with SAD
Estimated Value 29.69
Confidence Interval (2-Sided) 95%
25.42 to 34.49
Estimation Comments The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.
5.Primary Outcome
Title Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison
Hide Description 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.
Time Frame Baseline (Year 0 of initial studies) up to Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.
Arm/Group Title IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)
Hide Arm/Group Description:
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Overall Number of Participants Analyzed 139 139 143 143
Measure Type: Count of Participants
Unit of Measure: Participants
13 11 29 17
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with SAD
Estimated Value 9.35
Confidence Interval (2-Sided) 95%
5.54 to 15.56
Estimation Comments The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with SAD
Estimated Value 7.95
Confidence Interval (2-Sided) 95%
4.48 to 13.90
Estimation Comments The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with SAD
Estimated Value 20.42
Confidence Interval (2-Sided) 95%
14.67 to 28.03
Estimation Comments The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with SAD
Estimated Value 11.99
Confidence Interval (2-Sided) 95%
7.63 to 18.58
Estimation Comments The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.
6.Secondary Outcome
Title Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6
Hide Description 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.
Time Frame Baseline (Year 0) up to Year 6
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study.
Overall Number of Participants Analyzed 235 321
Measure Type: Count of Participants
Unit of Measure: Participants
74 130
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alemtuzumab Treatment CAMMS323 Extension
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with SRD
Estimated Value 32.69
Confidence Interval (2-Sided) 95%
26.96 to 39.28
Estimation Comments The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Alemtuzumab Treatment CAMMS324 Extension
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with SRD
Estimated Value 42.46
Confidence Interval (2-Sided) 95%
37.08 to 48.28
Estimation Comments The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.
7.Secondary Outcome
Title Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study
Hide Description 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.
Time Frame Extension study (CAMMS03409) baseline up to Extension Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)
Hide Arm/Group Description:
Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Overall Number of Participants Analyzed 65 102
Measure Type: Count of Participants
Unit of Measure: Participants
11 14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with SRD
Estimated Value 16.92
Confidence Interval (2-Sided) 95%
9.75 to 28.47
Estimation Comments The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage with SRD
Estimated Value 13.89
Confidence Interval (2-Sided) 95%
8.47 to 22.33
Estimation Comments The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.
8.Secondary Outcome
Title Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6
Hide Description EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
Overall Number of Participants Analyzed 326 370
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Year 3
-0.08
(-0.20 to 0.04)
-0.02
(-0.14 to 0.10)
Change at Year 4
-0.06
(-0.19 to 0.07)
0.06
(-0.07 to 0.19)
Change at Year 5
0.06
(-0.08 to 0.19)
0.13
(-0.01 to 0.27)
Change at Year 6
0.09
(-0.04 to 0.23)
0.18
(0.03 to 0.32)
9.Secondary Outcome
Title Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison
Hide Description EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), 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.
Time Frame Baseline (Year 0 of initial studies) up to Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.
Arm/Group Title IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)
Hide Arm/Group Description:
Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Overall Number of Participants Analyzed 139 139 143 143
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Year 0 - 2
-0.15
(-0.32 to 0.03)
-0.07
(-0.23 to 0.09)
0.11
(-0.05 to 0.26)
-0.02
(-0.18 to 0.14)
Year 3 - 4
-0.21
(-0.43 to 0.00)
0.08
(-0.11 to 0.27)
0.20
(-0.01 to 0.41)
0.13
(-0.05 to 0.31)
10.Secondary Outcome
Title Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment
Hide Description EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), 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.
Time Frame Retreatment baseline, Year 1, 2 and 3 after retreatment baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.
Arm/Group Title Alemtuzumab Retreatment
Hide Arm/Group Description:
Participants who received alemtuzumab in CAMMS323 or CAMMS324 who received an additional course of alemtuzumab in CAMMS03409.
Overall Number of Participants Analyzed 321
Mean (Standard Deviation)
Unit of Measure: units on a scale
Retreatment baseline Number Analyzed 307 participants
2.89  (1.514)
Change at Year 1 after retreatment baseline Number Analyzed 256 participants
-0.22  (1.033)
Change at Year 2 after retreatment baseline Number Analyzed 158 participants
-0.13  (1.109)
Change at Year 3 after retreatment baseline Number Analyzed 75 participants
0.07  (1.356)
11.Secondary Outcome
Title Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
Overall Number of Participants Analyzed 328 356
Measure Type: Number
Unit of Measure: percentage of participants
Year 3 Number Analyzed 328 participants 356 participants
72.6 68.8
Year 4 Number Analyzed 323 participants 332 participants
70.3 70.2
Year 5 Number Analyzed 319 participants 321 participants
70.2 67.0
Year 6 Number Analyzed 307 participants 312 participants
66.8 69.6
12.Secondary Outcome
Title Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment
Hide Description 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.
Time Frame Baseline (Year 0 of initial studies) up to Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.
Arm/Group Title IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)
Hide Arm/Group Description:
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Overall Number of Participants Analyzed 139 139 143 143
Measure Type: Number
Unit of Measure: percentage of participants
Year 0 - 1 Number Analyzed 135 participants 135 participants 139 participants 138 participants
57 79.3 44.6 63.8
Year 0 - 2 Number Analyzed 135 participants 132 participants 139 participants 131 participants
60.7 81.8 47.5 81.7
13.Secondary Outcome
Title Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.
Arm/Group Title Alemtuzumab Retreatment
Hide Arm/Group Description:
Participants who received alemtuzumab in CAMMS323 or CAMMS324 who received an additional course of alemtuzumab in CAMMS03409.
Overall Number of Participants Analyzed 321
Measure Type: Number
Unit of Measure: percentage of participants
Retreatment baseline Number Analyzed 315 participants
49.2
Year 1 after retreatment baseline Number Analyzed 301 participants
64.1
Year 2 after retreatment baseline Number Analyzed 197 participants
66.0
Year 3 after retreatment baseline Number Analyzed 113 participants
60.2
14.Secondary Outcome
Title Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
Overall Number of Participants Analyzed 332 364
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Year 3 Number Analyzed 332 participants 364 participants
-6.57  (29.96) 1.69  (31.62)
Change at Year 4 Number Analyzed 327 participants 339 participants
-5.04  (32.88) 4.97  (41.11)
Change at Year 5 Number Analyzed 324 participants 336 participants
-4.09  (36.99) 12.37  (80.74)
Change at Year 6 Number Analyzed 309 participants 319 participants
-2.68  (42.92) 11.46  (73.91)
15.Secondary Outcome
Title Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
Overall Number of Participants Analyzed 330 356
Measure Type: Number
Unit of Measure: percentage of participants
Year 3 Number Analyzed 330 participants 356 participants
90.6 86.5
Year 4 Number Analyzed 325 participants 331 participants
87.1 88.8
Year 5 Number Analyzed 321 participants 321 participants
87.5 89.4
Year 6 Number Analyzed 308 participants 310 participants
86.7 90.0
16.Secondary Outcome
Title Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
Overall Number of Participants Analyzed 325 355
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Year 3 Number Analyzed 325 participants 355 participants
-1.068  (1.185) -0.761  (1.240)
Change at Year 4 Number Analyzed 323 participants 331 participants
-1.251  (1.228) -0.949  (1.341)
Change at Year 5 Number Analyzed 321 participants 317 participants
-1.437  (1.317) -0.983  (1.374)
Change at Year 6 Number Analyzed 308 participants 315 participants
-1.601  (1.370) -1.051  (1.472)
17.Secondary Outcome
Title Percentage of Relapse Free Participants
Hide 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.
Time Frame Year 3, 4, 5 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
Overall Number of Participants Analyzed 353 391
Measure Type: Number
Unit of Measure: percentage of participants
Year 3 84.14 80.56
Year 4 86.84 79.27
Year 5 87.35 83.29
Year 6 88.96 86.86
18.Secondary Outcome
Title Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6
Hide 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 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
Overall Number of Participants Analyzed 340 375
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Year 3
1.90
(0.85 to 2.95)
1.72
(0.84 to 2.60)
Change at Year 4
2.15
(1.10 to 3.20)
1.34
(0.40 to 2.28)
Change at Year 5
1.85
(0.75 to 2.94)
1.34
(0.39 to 2.29)
Change at Year 6
1.65
(0.56 to 2.74)
1.00
(-0.03 to 2.03)
19.Secondary Outcome
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
Hide 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 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.
Time Frame Baseline (Year 0 of initial studies) up to Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.
Arm/Group Title IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)
Hide Arm/Group Description:
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Overall Number of Participants Analyzed 139 139 143 143
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Year 1
1.16
(-0.48 to 2.81)
2.00
(0.43 to 3.57)
0.79
(-0.34 to 1.93)
1.56
(0.38 to 2.75)
Year 2
1.20
(-0.54 to 2.95)
0.41
(-1.21 to 2.04)
0.45
(-0.86 to 1.76)
1.31
(0.14 to 2.48)
20.Secondary Outcome
Title Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
Overall Number of Participants Analyzed 340 375
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Year 3
2.43
(1.07 to 3.78)
1.96
(0.85 to 3.07)
Change at Year 4
3.17
(1.85 to 4.49)
1.91
(0.77 to 3.05)
Change at Year 5
2.54
(1.23 to 3.85)
1.75
(0.59 to 2.92)
Change at Year 6
2.41
(1.01 to 3.80)
1.58
(0.35 to 2.82)
21.Secondary Outcome
Title Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.
Arm/Group Title IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)
Hide Arm/Group Description:
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Overall Number of Participants Analyzed 139 139 143 143
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Year 1
2.88
(0.49 to 5.27)
1.98
(-0.46 to 4.43)
1.83
(0.30 to 3.36)
1.21
(-0.31 to 2.74)
Change at Year 2
2.32
(-0.11 to 4.74)
2.08
(-0.38 to 4.54)
1.65
(0.05 to 3.25)
1.65
(-0.01 to 3.31)
22.Secondary Outcome
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
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
Overall Number of Participants Analyzed 340 372
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Year 3
5.28
(2.03 to 8.52)
4.55
(1.89 to 7.21)
Change at Year 4
6.81
(3.55 to 10.08)
3.65
(0.98 to 6.32)
Change at Year 5
4.82
(1.55 to 8.10)
3.57
(0.78 to 6.37)
Change at Year 6
4.40
(1.03 to 7.78)
3.16
(0.07 to 6.25)
23.Secondary Outcome
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
Hide Description 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.
Time Frame Baseline (Year 0 of initial studies) up to Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.
Arm/Group Title IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)
Hide Arm/Group Description:
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Overall Number of Participants Analyzed 139 139 143 143
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Year 1
4.27
(-1.17 to 9.72)
4.82
(0.10 to 9.53)
3.19
(-0.12 to 6.51)
5.83
(2.74 to 8.92)
Change at Year 2
1.88
(-3.63 to 7.38)
3.10
(-2.16 to 8.35)
0.93
(-2.86 to 4.71)
4.66
(1.07 to 8.24)
24.Secondary Outcome
Title Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.
Arm/Group Title Alemtuzumab Treatment CAMMS323 Extension Alemtuzumab Treatment CAMMS324 Extension
Hide Arm/Group Description:
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
Overall Number of Participants Analyzed 337 374
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Year 3
3.505
(1.438 to 5.572)
2.859
(1.008 to 4.710)
Change at Year 4
5.144
(3.078 to 7.210)
2.992
(1.145 to 4.838)
Change at Year 5
4.409
(2.303 to 6.515)
3.034
(1.169 to 4.898)
Change at Year 6
4.134
(1.946 to 6.323)
3.155
(0.933 to 5.377)
25.Secondary Outcome
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
Hide Description 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.
Time Frame Baseline (Year 0 of initial studies) up to Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.
Arm/Group Title IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)
Hide Arm/Group Description:
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
Overall Number of Participants Analyzed 139 139 143 143
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Year 1
4.165
(0.639 to 7.691)
4.576
(1.419 to 7.733)
1.663
(-0.893 to 4.219)
4.337
(1.614 to 7.059)
Change at Year 2
2.359
(-1.319 to 6.037)
4.515
(1.407 to 7.622)
-0.712
(-3.552 to 2.129)
3.346
(0.324 to 6.368)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form in the extension study up to the end of extension study visit (up to Year 6) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs are treatment-emergent adverse events (TEAEs), AEs that developed/worsened during or at any time after first alemtuzumab treatment. Alemtuzumab TEAEs were defined as AEs with start dates and start times on or after the date and time of the first alemtuzumab treatment in CAMMS03409 or in prior studies (CAMMS223, CAMMS323, or CAMMS324).
 
Arm/Group Title Alemtuzumab
Hide Arm/Group Description Participants enrolled in any of the previous studies who had received alemtuzumab. Participants enrolled in any of the previous studies who had received IFNB-1a, who received alemtuzumab 12 mg/day infusion in this study.
All-Cause Mortality
Alemtuzumab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Alemtuzumab
Affected / at Risk (%)
Total   376/1314 (28.61%) 
Blood and lymphatic system disorders   
Acquired haemophilia  1  1/1314 (0.08%) 
Anaemia  1  3/1314 (0.23%) 
Autoimmune haemolytic anaemia  1  1/1314 (0.08%) 
Autoimmune pancytopenia  1  1/1314 (0.08%) 
Febrile neutropenia  1  1/1314 (0.08%) 
Haemolytic anaemia  1  2/1314 (0.15%) 
Haemorrhagic anaemia  1  1/1314 (0.08%) 
Immune thrombocytopenic purpura  1  16/1314 (1.22%) 
Lymphadenopathy  1  1/1314 (0.08%) 
Neutropenia  1  1/1314 (0.08%) 
Pancytopenia  1  1/1314 (0.08%) 
Thrombocytopenia  1  1/1314 (0.08%) 
Cardiac disorders   
Acute myocardial infarction  1  3/1314 (0.23%) 
Angina pectoris  1  4/1314 (0.30%) 
Atrial fibrillation  1  1/1314 (0.08%) 
Bradycardia  1  2/1314 (0.15%) 
Bradycardia foetal  1  1/1314 (0.08%) 
Bradycardia neonatal  1  1/1314 (0.08%) 
Bundle branch block right  1  1/1314 (0.08%) 
Cardiac arrest  1  1/1314 (0.08%) 
Cardiac failure congestive  1  2/1314 (0.15%) 
Congestive cardiomyopathy  1  1/1314 (0.08%) 
Myocardial infarction  1  2/1314 (0.15%) 
Pericarditis  1  1/1314 (0.08%) 
Sinus bradycardia  1  1/1314 (0.08%) 
Tachycardia  1  3/1314 (0.23%) 
Congenital, familial and genetic disorders   
Foetal cystic hygroma  1  1/1314 (0.08%) 
Ear and labyrinth disorders   
Vertigo  1  1/1314 (0.08%) 
Endocrine disorders   
Autoimmune hypothyroidism  1  1/1314 (0.08%) 
Autoimmune thyroiditis  1  4/1314 (0.30%) 
Basedow's disease  1  39/1314 (2.97%) 
Goitre  1  3/1314 (0.23%) 
Hyperparathyroidism  1  1/1314 (0.08%) 
Hyperthyroidism  1  14/1314 (1.07%) 
Hypothyroidism  1  4/1314 (0.30%) 
Eye disorders   
Cataract  1  1/1314 (0.08%) 
Endocrine ophthalmopathy  1  4/1314 (0.30%) 
Glaucoma  1  1/1314 (0.08%) 
Iridocyclitis  1  1/1314 (0.08%) 
Optic atrophy  1  1/1314 (0.08%) 
Vision blurred  1  1/1314 (0.08%) 
Gastrointestinal disorders   
Abdominal distension  1  1/1314 (0.08%) 
Abdominal hernia  1  1/1314 (0.08%) 
Abdominal pain  1  11/1314 (0.84%) 
Abdominal pain upper  1  1/1314 (0.08%) 
Ascites  1  1/1314 (0.08%) 
Colitis  1  3/1314 (0.23%) 
Colitis ischaemic  1  1/1314 (0.08%) 
Constipation  1  1/1314 (0.08%) 
Diarrhoea  1  3/1314 (0.23%) 
Duodenitis  1  1/1314 (0.08%) 
Enteritis  1  1/1314 (0.08%) 
Faecaloma  1  1/1314 (0.08%) 
Gastric ulcer haemorrhage  1  1/1314 (0.08%) 
Gastritis  1  2/1314 (0.15%) 
Impaired gastric emptying  1  1/1314 (0.08%) 
Inguinal hernia  1  2/1314 (0.15%) 
Nausea  1  7/1314 (0.53%) 
Oesophagitis  1  1/1314 (0.08%) 
Pancreatic fistula  1  1/1314 (0.08%) 
Pancreatic pseudocyst  1  1/1314 (0.08%) 
Pancreatitis  1  1/1314 (0.08%) 
Pancreatitis acute  1  1/1314 (0.08%) 
Peptic ulcer  1  1/1314 (0.08%) 
Small intestinal obstruction  1  1/1314 (0.08%) 
Upper gastrointestinal haemorrhage  1  1/1314 (0.08%) 
Vomiting  1  6/1314 (0.46%) 
General disorders   
Catheter site pain  1  1/1314 (0.08%) 
Chest pain  1  1/1314 (0.08%) 
Chills  1  1/1314 (0.08%) 
Death  1  1/1314 (0.08%) 
Device dislocation  1  1/1314 (0.08%) 
Fatigue  1  1/1314 (0.08%) 
Inflammation  1  1/1314 (0.08%) 
Non-cardiac chest pain  1  2/1314 (0.15%) 
Perforated ulcer  1  1/1314 (0.08%) 
Pyrexia  1  2/1314 (0.15%) 
Hepatobiliary disorders   
Biliary dyskinesia  1  1/1314 (0.08%) 
Cholangitis  1  1/1314 (0.08%) 
Cholecystitis  1  4/1314 (0.30%) 
Cholecystitis acute  1  2/1314 (0.15%) 
Cholelithiasis  1  4/1314 (0.30%) 
Hepatitis acute  1  1/1314 (0.08%) 
Sphincter of Oddi dysfunction  1  1/1314 (0.08%) 
Immune system disorders   
Anaphylactoid reaction  1  1/1314 (0.08%) 
Drug hypersensitivity  1  1/1314 (0.08%) 
Hypersensitivity  1  3/1314 (0.23%) 
Infections and infestations   
Abscess bacterial  1  1/1314 (0.08%) 
Abscess limb  1  1/1314 (0.08%) 
Appendicitis  1  2/1314 (0.15%) 
Appendicitis perforated  1  1/1314 (0.08%) 
Bone abscess  1  1/1314 (0.08%) 
Breast abscess  1  1/1314 (0.08%) 
Bronchitis  1  1/1314 (0.08%) 
Cellulitis  1  6/1314 (0.46%) 
Chronic hepatitis C  1  1/1314 (0.08%) 
Device related infection  1  1/1314 (0.08%) 
Diverticulitis  1  2/1314 (0.15%) 
Endometritis  1  1/1314 (0.08%) 
Escherichia urinary tract infection  1  1/1314 (0.08%) 
Furuncle  1  1/1314 (0.08%) 
Gastroenteritis  1  7/1314 (0.53%) 
Gastroenteritis bacterial  1  1/1314 (0.08%) 
Gastroenteritis viral  1  2/1314 (0.15%) 
HIV infection  1  1/1314 (0.08%) 
Helicobacter infection  1  1/1314 (0.08%) 
Herpes zoster  1  10/1314 (0.76%) 
Infection  1  1/1314 (0.08%) 
Infectious colitis  1  1/1314 (0.08%) 
Infective myositis  1  1/1314 (0.08%) 
Influenza  1  2/1314 (0.15%) 
Lower respiratory tract infection  1  2/1314 (0.15%) 
Lung abscess  1  1/1314 (0.08%) 
Oral herpes  1  1/1314 (0.08%) 
Pancreas infection  1  1/1314 (0.08%) 
Pneumonia  1  13/1314 (0.99%) 
Pneumonia fungal  1  1/1314 (0.08%) 
Pneumonia legionella  1  1/1314 (0.08%) 
Post procedural infection  1  1/1314 (0.08%) 
Pulmonary tuberculosis  1  1/1314 (0.08%) 
Pyelonephritis  1  4/1314 (0.30%) 
Pyelonephritis acute  1  1/1314 (0.08%) 
Respiratory tract infection viral  1  2/1314 (0.15%) 
Scrotal abscess  1  1/1314 (0.08%) 
Sepsis  1  8/1314 (0.61%) 
Soft tissue infection  1  1/1314 (0.08%) 
Staphylococcal abscess  1  1/1314 (0.08%) 
Subcutaneous abscess  1  1/1314 (0.08%) 
Tracheobronchitis  1  1/1314 (0.08%) 
Tubo-ovarian abscess  1  1/1314 (0.08%) 
Urinary tract infection  1  7/1314 (0.53%) 
Urosepsis  1  1/1314 (0.08%) 
Varicella zoster virus infection  1  1/1314 (0.08%) 
Viral infection  1  1/1314 (0.08%) 
Injury, poisoning and procedural complications   
Accidental overdose  1  1/1314 (0.08%) 
Ankle fracture  1  1/1314 (0.08%) 
Cartilage injury  1  1/1314 (0.08%) 
Cervical vertebral fracture  1  1/1314 (0.08%) 
Concussion  1  3/1314 (0.23%) 
Contusion  1  2/1314 (0.15%) 
Femur fracture  1  1/1314 (0.08%) 
Fibula fracture  1  2/1314 (0.15%) 
Gastrostomy failure  1  1/1314 (0.08%) 
Hip fracture  1  1/1314 (0.08%) 
Humerus fracture  1  1/1314 (0.08%) 
Incision site oedema  1  1/1314 (0.08%) 
Intentional overdose  1  2/1314 (0.15%) 
Laceration  1  2/1314 (0.15%) 
Ligament sprain  1  1/1314 (0.08%) 
Lumbar vertebral fracture  1  1/1314 (0.08%) 
Meniscus injury  1  1/1314 (0.08%) 
Multiple fractures  1  1/1314 (0.08%) 
Overdose  1  2/1314 (0.15%) 
Pancreatic injury  1  1/1314 (0.08%) 
Pelvic fracture  1  1/1314 (0.08%) 
Post lumbar puncture syndrome  1  1/1314 (0.08%) 
Post procedural fistula  1  1/1314 (0.08%) 
Post procedural haematoma  1  1/1314 (0.08%) 
Procedural nausea  1  1/1314 (0.08%) 
Procedural pain  1  1/1314 (0.08%) 
Skull fractured base  1  1/1314 (0.08%) 
Spinal column injury  1  1/1314 (0.08%) 
Splenic rupture  1  1/1314 (0.08%) 
Subdural haematoma  1  1/1314 (0.08%) 
Tibia fracture  1  2/1314 (0.15%) 
Ulna fracture  1  1/1314 (0.08%) 
Wound  1  1/1314 (0.08%) 
Wound dehiscence  1  1/1314 (0.08%) 
Wrist fracture  1  2/1314 (0.15%) 
Investigations   
Blood creatinine increased  1  1/1314 (0.08%) 
Urine ketone body present  1  1/1314 (0.08%) 
Metabolism and nutrition disorders   
Dehydration  1  6/1314 (0.46%) 
Diabetic ketoacidosis  1  1/1314 (0.08%) 
Electrolyte imbalance  1  1/1314 (0.08%) 
Hyperglycaemia  1  1/1314 (0.08%) 
Hypocalcaemia  1  2/1314 (0.15%) 
Hypokalaemia  1  2/1314 (0.15%) 
Hypophosphataemia  1  1/1314 (0.08%) 
Malnutrition  1  1/1314 (0.08%) 
Obesity  1  1/1314 (0.08%) 
Type 1 diabetes mellitus  1  1/1314 (0.08%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/1314 (0.15%) 
Arthritis  1  1/1314 (0.08%) 
Back disorder  1  1/1314 (0.08%) 
Back pain  1  2/1314 (0.15%) 
Chondropathy  1  1/1314 (0.08%) 
Costochondritis  1  2/1314 (0.15%) 
Flank pain  1  2/1314 (0.15%) 
Haemarthrosis  1  1/1314 (0.08%) 
Joint effusion  1  1/1314 (0.08%) 
Joint instability  1  1/1314 (0.08%) 
Joint range of motion decreased  1  1/1314 (0.08%) 
Muscle spasms  1  1/1314 (0.08%) 
Muscular weakness  1  2/1314 (0.15%) 
Musculoskeletal chest pain  1  2/1314 (0.15%) 
Musculoskeletal stiffness  1  1/1314 (0.08%) 
Osteoarthritis  1  2/1314 (0.15%) 
Osteonecrosis  1  2/1314 (0.15%) 
Pain in jaw  1  1/1314 (0.08%) 
Plantar fasciitis  1  1/1314 (0.08%) 
Rotator cuff syndrome  1  1/1314 (0.08%) 
SAPHO syndrome  1  1/1314 (0.08%) 
Spinal pain  1  1/1314 (0.08%) 
Temporomandibular joint syndrome  1  1/1314 (0.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Anogenital warts  1  3/1314 (0.23%) 
B-cell lymphoma  1  1/1314 (0.08%) 
Basal cell carcinoma  1  1/1314 (0.08%) 
Benign hydatidiform mole  1  1/1314 (0.08%) 
Benign neoplasm of thyroid gland  1  2/1314 (0.15%) 
Breast cancer  1  2/1314 (0.15%) 
Castleman's disease  1  1/1314 (0.08%) 
Cervix carcinoma stage II  1  1/1314 (0.08%) 
Insulinoma  1  1/1314 (0.08%) 
Invasive ductal breast carcinoma  1  1/1314 (0.08%) 
Invasive lobular breast carcinoma  1  1/1314 (0.08%) 
Malignant melanoma  1  1/1314 (0.08%) 
Malignant melanoma in situ  1  1/1314 (0.08%) 
Meningioma benign  1  1/1314 (0.08%) 
Metastatic malignant melanoma  1  1/1314 (0.08%) 
Neoplasm skin  1  1/1314 (0.08%) 
Non-small cell lung cancer  1  1/1314 (0.08%) 
Ovarian adenoma  1  1/1314 (0.08%) 
Pancreatic neuroendocrine tumour  1  1/1314 (0.08%) 
Papillary thyroid cancer  1  3/1314 (0.23%) 
Parathyroid tumour benign  1  1/1314 (0.08%) 
Pituitary tumour  1  1/1314 (0.08%) 
Squamous cell carcinoma  1  1/1314 (0.08%) 
Thyroid cancer  1  1/1314 (0.08%) 
Uterine leiomyoma  1  5/1314 (0.38%) 
Vulval cancer stage 0  1  1/1314 (0.08%) 
Nervous system disorders   
Altered state of consciousness  1  1/1314 (0.08%) 
Basal ganglia haemorrhage  1  1/1314 (0.08%) 
Cerebral haemorrhage  1  2/1314 (0.15%) 
Complex partial seizures  1  1/1314 (0.08%) 
Depressed level of consciousness  1  1/1314 (0.08%) 
Dizziness  1  2/1314 (0.15%) 
Dysarthria  1  1/1314 (0.08%) 
Embolic stroke  1  1/1314 (0.08%) 
Headache  1  7/1314 (0.53%) 
Intracranial aneurysm  1  1/1314 (0.08%) 
Intraventricular haemorrhage  1  1/1314 (0.08%) 
Loss of consciousness  1  2/1314 (0.15%) 
Migraine  1  1/1314 (0.08%) 
Multiple sclerosis  1  4/1314 (0.30%) 
Multiple sclerosis relapse  1  67/1314 (5.10%) 
Optic neuritis  1  1/1314 (0.08%) 
Seizure  1  4/1314 (0.30%) 
Status epilepticus  1  1/1314 (0.08%) 
Syncope  1  9/1314 (0.68%) 
Tension headache  1  1/1314 (0.08%) 
Tremor  1  1/1314 (0.08%) 
Trigeminal neuralgia  1  3/1314 (0.23%) 
Uhthoff's phenomenon  1  6/1314 (0.46%) 
Pregnancy, puerperium and perinatal conditions   
Abortion  1  1/1314 (0.08%) 
Abortion missed  1  3/1314 (0.23%) 
Foetal cardiac disorder  1  1/1314 (0.08%) 
Foetal death  1  1/1314 (0.08%) 
Foetal-maternal haemorrhage  1  1/1314 (0.08%) 
HELLP syndrome  1  1/1314 (0.08%) 
Low birth weight baby  1  1/1314 (0.08%) 
Peripartum cardiomyopathy  1  1/1314 (0.08%) 
Placental insufficiency  1  1/1314 (0.08%) 
Pre-eclampsia  1  1/1314 (0.08%) 
Premature separation of placenta  1  2/1314 (0.15%) 
Psychiatric disorders   
Adjustment disorder  1  1/1314 (0.08%) 
Affective disorder  1  1/1314 (0.08%) 
Bipolar II disorder  1  1/1314 (0.08%) 
Completed suicide  1  2/1314 (0.15%) 
Depression  1  2/1314 (0.15%) 
Hypomania  1  1/1314 (0.08%) 
Insomnia  1  1/1314 (0.08%) 
Major depression  1  1/1314 (0.08%) 
Mental status changes  1  4/1314 (0.30%) 
Post-traumatic amnestic disorder  1  1/1314 (0.08%) 
Psychogenic pain disorder  1  1/1314 (0.08%) 
Psychogenic tremor  1  1/1314 (0.08%) 
Psychotic disorder  1  1/1314 (0.08%) 
Schizoaffective disorder bipolar type  1  1/1314 (0.08%) 
Self injurious behaviour  1  1/1314 (0.08%) 
Suicidal ideation  1  6/1314 (0.46%) 
Suicide attempt  1  1/1314 (0.08%) 
Renal and urinary disorders   
Acute kidney injury  1  2/1314 (0.15%) 
Automatic bladder  1  1/1314 (0.08%) 
Calculus bladder  1  1/1314 (0.08%) 
Calculus ureteric  1  1/1314 (0.08%) 
Glomerulonephritis  1  1/1314 (0.08%) 
Glomerulonephritis membranous  1  1/1314 (0.08%) 
Haematuria  1  1/1314 (0.08%) 
Nephrolithiasis  1  4/1314 (0.30%) 
Renal colic  1  1/1314 (0.08%) 
Renal failure  1  1/1314 (0.08%) 
Renal mass  1  1/1314 (0.08%) 
Renal tubular necrosis  1  1/1314 (0.08%) 
Urinary retention  1  4/1314 (0.30%) 
Reproductive system and breast disorders   
Adnexa uteri mass  1  1/1314 (0.08%) 
Cervical dysplasia  1  4/1314 (0.30%) 
Cystocele  1  2/1314 (0.15%) 
Endometrial hyperplasia  1  1/1314 (0.08%) 
Endometriosis  1  2/1314 (0.15%) 
Menometrorrhagia  1  1/1314 (0.08%) 
Menorrhagia  1  2/1314 (0.15%) 
Ovarian cyst  1  6/1314 (0.46%) 
Ovarian haemorrhage  1  1/1314 (0.08%) 
Parovarian cyst  1  1/1314 (0.08%) 
Pelvic adhesions  1  1/1314 (0.08%) 
Rectocele  1  2/1314 (0.15%) 
Vaginal haemorrhage  1  2/1314 (0.15%) 
Vulvar dysplasia  1  1/1314 (0.08%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/1314 (0.08%) 
Apnoea neonatal  1  1/1314 (0.08%) 
Asthma  1  2/1314 (0.15%) 
Bronchospasm  1  1/1314 (0.08%) 
Chronic obstructive pulmonary disease  1  1/1314 (0.08%) 
Dyspnoea  1  3/1314 (0.23%) 
Eosinophilic pneumonia  1  1/1314 (0.08%) 
Hiccups  1  1/1314 (0.08%) 
Interstitial lung disease  1  1/1314 (0.08%) 
Pleural effusion  1  1/1314 (0.08%) 
Pleurisy  1  2/1314 (0.15%) 
Pneumonia aspiration  1  2/1314 (0.15%) 
Pneumonitis  1  1/1314 (0.08%) 
Pneumothorax spontaneous  1  1/1314 (0.08%) 
Pulmonary embolism  1  2/1314 (0.15%) 
Respiratory failure  1  1/1314 (0.08%) 
Sleep apnoea syndrome  1  1/1314 (0.08%) 
Skin and subcutaneous tissue disorders   
Erythema nodosum  1  1/1314 (0.08%) 
Hyperhidrosis  1  1/1314 (0.08%) 
Polymorphic eruption of pregnancy  1  1/1314 (0.08%) 
Rash  1  1/1314 (0.08%) 
Rash generalised  1  2/1314 (0.15%) 
Skin ulcer  1  1/1314 (0.08%) 
Urticaria  1  2/1314 (0.15%) 
Surgical and medical procedures   
Thyroidectomy  1  1/1314 (0.08%) 
Vascular disorders   
Deep vein thrombosis  1  4/1314 (0.30%) 
Haematoma  1  1/1314 (0.08%) 
Hypertension  1  3/1314 (0.23%) 
Hypertensive crisis  1  1/1314 (0.08%) 
Hypotension  1  1/1314 (0.08%) 
Orthostatic hypotension  1  1/1314 (0.08%) 
Pallor  1  1/1314 (0.08%) 
Peripheral arterial occlusive disease  1  1/1314 (0.08%) 
Thrombophlebitis  1  1/1314 (0.08%) 
Vasculitis  1  1/1314 (0.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alemtuzumab
Affected / at Risk (%)
Total   1225/1314 (93.23%) 
Cardiac disorders   
Tachycardia  1  86/1314 (6.54%) 
Endocrine disorders   
Autoimmune thyroiditis  1  67/1314 (5.10%) 
Basedow's disease  1  165/1314 (12.56%) 
Hyperthyroidism  1  142/1314 (10.81%) 
Hypothyroidism  1  140/1314 (10.65%) 
Eye disorders   
Vision blurred  1  75/1314 (5.71%) 
Gastrointestinal disorders   
Abdominal pain  1  72/1314 (5.48%) 
Constipation  1  104/1314 (7.91%) 
Diarrhoea  1  170/1314 (12.94%) 
Dyspepsia  1  71/1314 (5.40%) 
Nausea  1  206/1314 (15.68%) 
Vomiting  1  130/1314 (9.89%) 
General disorders   
Fatigue  1  280/1314 (21.31%) 
Pain  1  85/1314 (6.47%) 
Pyrexia  1  228/1314 (17.35%) 
Infections and infestations   
Bronchitis  1  133/1314 (10.12%) 
Gastroenteritis  1  81/1314 (6.16%) 
Gastroenteritis viral  1  85/1314 (6.47%) 
Herpes zoster  1  123/1314 (9.36%) 
Influenza  1  155/1314 (11.80%) 
Nasopharyngitis  1  382/1314 (29.07%) 
Oral herpes  1  78/1314 (5.94%) 
Pharyngitis  1  68/1314 (5.18%) 
Sinusitis  1  186/1314 (14.16%) 
Upper respiratory tract infection  1  272/1314 (20.70%) 
Urinary tract infection  1  360/1314 (27.40%) 
Injury, poisoning and procedural complications   
Contusion  1  141/1314 (10.73%) 
Fall  1  87/1314 (6.62%) 
Investigations   
Blood creatinine increased  1  68/1314 (5.18%) 
Protein urine present  1  78/1314 (5.94%) 
Metabolism and nutrition disorders   
Vitamin D deficiency  1  83/1314 (6.32%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  216/1314 (16.44%) 
Back pain  1  205/1314 (15.60%) 
Muscle spasms  1  132/1314 (10.05%) 
Muscular weakness  1  113/1314 (8.60%) 
Musculoskeletal pain  1  75/1314 (5.71%) 
Myalgia  1  80/1314 (6.09%) 
Pain in extremity  1  189/1314 (14.38%) 
Nervous system disorders   
Dizziness  1  130/1314 (9.89%) 
Headache  1  437/1314 (33.26%) 
Hypoaesthesia  1  176/1314 (13.39%) 
Multiple sclerosis  1  70/1314 (5.33%) 
Multiple sclerosis relapse  1  508/1314 (38.66%) 
Paraesthesia  1  168/1314 (12.79%) 
Psychiatric disorders   
Anxiety  1  133/1314 (10.12%) 
Depression  1  154/1314 (11.72%) 
Insomnia  1  231/1314 (17.58%) 
Renal and urinary disorders   
Haematuria  1  92/1314 (7.00%) 
Proteinuria  1  122/1314 (9.28%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  127/1314 (9.67%) 
Oropharyngeal pain  1  91/1314 (6.93%) 
Skin and subcutaneous tissue disorders   
Rash  1  208/1314 (15.83%) 
Rash generalised  1  110/1314 (8.37%) 
Urticaria  1  96/1314 (7.31%) 
Vascular disorders   
Flushing  1  79/1314 (6.01%) 
Hypertension  1  92/1314 (7.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
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Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-US@sanofi.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00930553    
Other Study ID Numbers: CAMMS03409
2009-010788-18 ( EudraCT Number )
LTE12824 ( Other Identifier: Sanofi )
First Submitted: June 26, 2009
First Posted: June 30, 2009
Results First Submitted: February 16, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017