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Trial record 2 of 2 for:    CAMMS324

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

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ClinicalTrials.gov Identifier: NCT00548405
Recruitment Status : Completed
First Posted : October 24, 2007
Results First Posted : January 8, 2015
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Sclerosis, Relapsing-Remitting
Interventions Biological: Alemtuzumab 12 mg
Biological: Alemtuzumab 24 mg
Biological: Interferon beta-1a
Enrollment 840
Recruitment Details Participants were screened at 192 investigational sites between October 10, 2007 and September 15, 2011.
Pre-assignment Details  
Arm/Group Title Interferon Beta-1a Alemtuzumab 12 mg Alemtuzumab 24mg
Hide Arm/Group Description Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion. Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12. Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
Period Title: Overall Study
Started 231 [1] 436 [1] 173 [1]
Treated 202 [2] 426 [2] 170 [2]
Completed 175 416 164
Not Completed 56 20 9
Reason Not Completed
Adverse Event             6             2             0
Lack of Efficacy             6             0             0
Physician Decision             3             4             1
Pregnancy             1             0             0
Protocol Violation             1             0             0
Withdrawal by Subject             36             12             5
Lost to Follow-up             1             1             2
Death             0             1             1
Sponsor decision             1             0             0
Randomized but not treated             1             0             0
[1]
Randomized.
[2]
All randomized participants who received at least 1 dose of study drug as per initial randomization.
Arm/Group Title Interferon Beta-1a Alemtuzumab 12 mg Alemtuzumab 24mg Total
Hide Arm/Group Description Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion. Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12. Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12. Total of all reporting groups
Overall Number of Baseline Participants 202 426 170 798
Hide Baseline Analysis Population Description
Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study drug as per initial randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 202 participants 426 participants 170 participants 798 participants
35.8  (8.77) 34.8  (8.36) 35.1  (8.40) 35.1  (8.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 426 participants 170 participants 798 participants
Female
131
  64.9%
281
  66.0%
120
  70.6%
532
  66.7%
Male
71
  35.1%
145
  34.0%
50
  29.4%
266
  33.3%
Time Since First Relapse  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 202 participants 426 participants 170 participants 798 participants
4.1
(0.4 to 10.1)
3.8
(0.2 to 14.4)
3.7
(0.2 to 16.9)
3.8
(0.2 to 16.9)
Number of Relapse Episodes in the Preceding 2 Years   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 202 participants 426 participants 170 participants 798 participants
1 Relapse 7 15 11 33
2 Relapses 109 215 94 418
Greater than or equal to 3 Relapses 86 196 65 347
[1]
Measure Description: Number of participants with 1, 2 or greater than or equal to 3 relapses are reported.
Expanded Disability Status Scale (EDSS) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 202 participants 426 participants 170 participants 798 participants
2.7  (1.21) 2.7  (1.26) 2.7  (1.17) 2.7  (1.22)
[1]
Measure Description: EDSS is an ordinal scale in half-point increments that quantifies disability in participants with multiple sclerosis (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).
1.Primary Outcome
Title Percentage of Participants With Sustained Accumulation of Disability (SAD)
Hide Description EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomized participants who received at least 1 dose of study drug as per initial randomization. Analysis was not performed for Alemtuzumab 24 mg as recruitment to this arm was closed early to reduce overall sample size, duration of enrollment period, overall duration of study.
Arm/Group Title Interferon Beta-1a Alemtuzumab 12 mg
Hide Arm/Group Description:
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
Overall Number of Participants Analyzed 202 426
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.13
(15.95 to 27.68)
12.71
(9.89 to 16.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab 12 mg
Comments Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariate was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0084
Comments Hochberg method was used to adjust for the two co-primary outcomes.
Method Cox Proportional Hazards Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.38 to 0.87
Estimation Comments [Not Specified]
2.Primary Outcome
Title Annualized Relapse Rate
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 that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.
Arm/Group Title Interferon Beta-1a Alemtuzumab 12 mg
Hide Arm/Group Description:
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
Overall Number of Participants Analyzed 202 426
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: relapses per participant per year
0.52
(0.41 to 0.66)
0.26
(0.21 to 0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab 12 mg
Comments Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Hochberg method was used to adjust for the two co-primary outcomes.
Method Proportional means regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.39 to 0.65
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Were Relapse Free at Year 2
Hide Description Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.
Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.
Arm/Group Title Interferon Beta-1a Alemtuzumab 12 mg
Hide Arm/Group Description:
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
Overall Number of Participants Analyzed 202 426
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46.70
(39.53 to 53.54)
65.38
(60.65 to 69.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab 12 mg
Comments Cox PH regression model with robust variance estimation and covariate adjustment for geographic region was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cox Proportional Hazards Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.41 to 0.69
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2
Hide Description EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.
Time Frame Baseline, Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.
Arm/Group Title Interferon Beta-1a Alemtuzumab 12 mg
Hide Arm/Group Description:
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
Overall Number of Participants Analyzed 174 413
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.21  (1.167) -0.20  (1.084)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab 12 mg
Comments The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wei-Lachin
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2
Hide Description MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.
Time Frame Baseline, Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.
Arm/Group Title Interferon Beta-1a Alemtuzumab 12 mg
Hide Arm/Group Description:
Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
Overall Number of Participants Analyzed 198 423
Mean (Standard Deviation)
Unit of Measure: Z-score
Baseline (n=198, 423) -0.03  (0.791) 0.02  (0.689)
Change at Year 2 (n=169, 399) -0.04  (0.449) 0.09  (0.358)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab 12 mg
Comments Change at Year 2: the analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Wei-Lachin
Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2
Hide Description Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)*100/ (lesion volume at Baseline).
Time Frame Baseline, Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.
Arm/Group Title Interferon Beta-1a Alemtuzumab 12 mg
Hide Arm/Group Description:
Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
Overall Number of Participants Analyzed 190 412
Mean (Standard Deviation)
Unit of Measure: percent change
2.41  (26.48) -1.12  (24.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab 12 mg
Comments Ranked ANCOVA models with covariate adjustment for geographic region and Baseline T2 lesion volume was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1371
Comments [Not Specified]
Method Ranked ANCOVA
Comments [Not Specified]
Time Frame First dose of study drug up to 2 years
Adverse Event Reporting Description If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.
 
Arm/Group Title Interferon Beta-1a Alemtuzumab 12 mg Alemtuzumab 24 mg Alemtuzumab (Pooled)
Hide Arm/Group Description Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion. Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12. Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12. Included all participants who received alemtuzumab 12 mg or 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg or 24 mg per day IV infusion on 3 consecutive days at Month 12.
All-Cause Mortality
Interferon Beta-1a Alemtuzumab 12 mg Alemtuzumab 24 mg Alemtuzumab (Pooled)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Interferon Beta-1a Alemtuzumab 12 mg Alemtuzumab 24 mg Alemtuzumab (Pooled)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/202 (21.78%)   85/435 (19.54%)   30/161 (18.63%)   115/596 (19.30%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Autoimmune thrombocytopenia * 1  0/202 (0.00%)  1/435 (0.23%)  2/161 (1.24%)  3/596 (0.50%) 
Febrile neutropenia * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Idiopathic thrombocytopenic purpura * 1  0/202 (0.00%)  2/435 (0.46%)  0/161 (0.00%)  2/596 (0.34%) 
Thrombocytopenia * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Cardiac disorders         
Angina pectoris * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Coronary artery disease * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Myocardial infarction * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Sick sinus syndrome * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Sinus tachycardia * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Tachycardia * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Endocrine disorders         
Goitre * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Hyperthyroidism * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Hypothyroidism * 1  0/202 (0.00%)  2/435 (0.46%)  1/161 (0.62%)  3/596 (0.50%) 
Eye disorders         
Eye pain * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Retinal pigment epitheliopathy * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Gastrointestinal disorders         
Abdominal pain * 1  1/202 (0.50%)  2/435 (0.46%)  0/161 (0.00%)  2/596 (0.34%) 
Diarrhoea * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Diverticulum * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Gastritis * 1  0/202 (0.00%)  1/435 (0.23%)  1/161 (0.62%)  2/596 (0.34%) 
Gastrointestinal necrosis * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Nausea * 1  1/202 (0.50%)  1/435 (0.23%)  1/161 (0.62%)  2/596 (0.34%) 
Pancreatitis * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Peptic ulcer perforation * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Sigmoiditis * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Small intestinal obstruction * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Umbilical hernia * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Vomiting * 1  1/202 (0.50%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
General disorders         
Abasia * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Chest discomfort * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Chest pain * 1  0/202 (0.00%)  2/435 (0.46%)  0/161 (0.00%)  2/596 (0.34%) 
Death * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Infusion related reaction * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Non-cardiac chest pain * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Oedema peripheral * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Pain * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Pyrexia * 1  0/202 (0.00%)  2/435 (0.46%)  0/161 (0.00%)  2/596 (0.34%) 
Hepatobiliary disorders         
Biliary colic * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Cholecystitis * 1  3/202 (1.49%)  2/435 (0.46%)  0/161 (0.00%)  2/596 (0.34%) 
Cholecystitis acute * 1  0/202 (0.00%)  2/435 (0.46%)  0/161 (0.00%)  2/596 (0.34%) 
Hepatitis acute * 1  1/202 (0.50%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Liver disorder * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Immune system disorders         
Allergy to arthropod sting * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Infections and infestations         
Appendicitis * 1  0/202 (0.00%)  2/435 (0.46%)  0/161 (0.00%)  2/596 (0.34%) 
Bronchitis * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Catheter site infection * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Diverticulitis * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Febrile infection * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Gastroenteritis * 1  0/202 (0.00%)  3/435 (0.69%)  1/161 (0.62%)  4/596 (0.67%) 
Herpes zoster * 1  0/202 (0.00%)  1/435 (0.23%)  2/161 (1.24%)  3/596 (0.50%) 
Influenza * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Injection site abscess * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Labyrinthitis * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Oesophageal candidiasis * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Pasteurella infection * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Pneumonia * 1  0/202 (0.00%)  4/435 (0.92%)  1/161 (0.62%)  5/596 (0.84%) 
Pulmonary tuberculosis * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Pyelonephritis * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Pyelonephritis chronic * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Tooth infection * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Upper respiratory tract infection * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Urinary tract infection * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Injury, poisoning and procedural complications         
Concussion * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Head injury * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Hip fracture * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Injury * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Jaw fracture * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Ligament sprain * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Lip injury * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Overdose * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Radius fracture * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Rib fracture * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Road traffic accident * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Sternal fracture * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Subdural haematoma * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Tendon injury * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Thoracic vertebral fracture * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Upper limb fracture * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Investigations         
Blood creatinine increased * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Metabolism and nutrition disorders         
Dehydration * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Plantar fasciitis * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Rotator cuff syndrome * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute myeloid leukaemia * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Basal cell carcinoma * 1  1/202 (0.50%)  1/435 (0.23%)  1/161 (0.62%)  2/596 (0.34%) 
Colon cancer * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Fibroadenoma of breast * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Parathyroid tumour benign * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Thyroid cancer * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Uterine leiomyoma * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Vulval cancer stage 0 * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Nervous system disorders         
Convulsion * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Headache * 1  1/202 (0.50%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Intracranial hypotension * 1  0/202 (0.00%)  1/435 (0.23%)  1/161 (0.62%)  2/596 (0.34%) 
Migraine * 1  0/202 (0.00%)  1/435 (0.23%)  1/161 (0.62%)  2/596 (0.34%) 
Monoparesis * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Multiple sclerosis * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Multiple sclerosis relapse * 1  25/202 (12.38%)  33/435 (7.59%)  3/161 (1.86%)  36/596 (6.04%) 
Post herpetic neuralgia * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Spinal cord compression * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Status migrainosus * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Psychiatric disorders         
Drug dependence * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Major depression * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Mania * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Suicidal ideation * 1  0/202 (0.00%)  1/435 (0.23%)  1/161 (0.62%)  2/596 (0.34%) 
Suicide attempt * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Renal and urinary disorders         
Automatic bladder * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Renal failure acute * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Reproductive system and breast disorders         
Cervical dysplasia * 1  0/202 (0.00%)  1/435 (0.23%)  1/161 (0.62%)  2/596 (0.34%) 
Dysfunctional uterine bleeding * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Dysmenorrhoea * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Menorrhagia * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Metrorrhagia * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Uterine prolapse * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Vulvar dysplasia * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Dyspnoea * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Haemoptysis * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Nasal septum deviation * 1  1/202 (0.50%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Oropharyngeal blistering * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Pleural effusion * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Pneumonia aspiration * 1  0/202 (0.00%)  2/435 (0.46%)  0/161 (0.00%)  2/596 (0.34%) 
Pneumonitis * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Pulmonary embolism * 1  1/202 (0.50%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Skin and subcutaneous tissue disorders         
Angioedema * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Rash * 1  0/202 (0.00%)  0/435 (0.00%)  2/161 (1.24%)  2/596 (0.34%) 
Urticaria * 1  0/202 (0.00%)  2/435 (0.46%)  1/161 (0.62%)  3/596 (0.50%) 
Surgical and medical procedures         
Female sterilisation * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Vascular disorders         
Hypertension * 1  0/202 (0.00%)  0/435 (0.00%)  1/161 (0.62%)  1/596 (0.17%) 
Thrombophlebitis * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Thrombosis * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
Venous thrombosis limb * 1  0/202 (0.00%)  1/435 (0.23%)  0/161 (0.00%)  1/596 (0.17%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Interferon Beta-1a Alemtuzumab 12 mg Alemtuzumab 24 mg Alemtuzumab (Pooled)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   189/202 (93.56%)   427/435 (98.16%)   159/161 (98.76%)   586/596 (98.32%) 
Blood and lymphatic system disorders         
Lymphopenia * 1  4/202 (1.98%)  23/435 (5.29%)  9/161 (5.59%)  32/596 (5.37%) 
Cardiac disorders         
Tachycardia * 1  1/202 (0.50%)  27/435 (6.21%)  10/161 (6.21%)  37/596 (6.21%) 
Eye disorders         
Vision blurred * 1  10/202 (4.95%)  21/435 (4.83%)  9/161 (5.59%)  30/596 (5.03%) 
Gastrointestinal disorders         
Abdominal pain * 1  6/202 (2.97%)  23/435 (5.29%)  18/161 (11.18%)  41/596 (6.88%) 
Abdominal pain upper * 1  6/202 (2.97%)  16/435 (3.68%)  11/161 (6.83%)  27/596 (4.53%) 
Constipation * 1  15/202 (7.43%)  19/435 (4.37%)  14/161 (8.70%)  33/596 (5.54%) 
Diarrhoea * 1  17/202 (8.42%)  58/435 (13.33%)  34/161 (21.12%)  92/596 (15.44%) 
Dyspepsia * 1  9/202 (4.46%)  32/435 (7.36%)  19/161 (11.80%)  51/596 (8.56%) 
Nausea * 1  21/202 (10.40%)  105/435 (24.14%)  51/161 (31.68%)  156/596 (26.17%) 
Vomiting * 1  8/202 (3.96%)  39/435 (8.97%)  26/161 (16.15%)  65/596 (10.91%) 
General disorders         
Asthenia * 1  10/202 (4.95%)  22/435 (5.06%)  9/161 (5.59%)  31/596 (5.20%) 
Chest discomfort * 1  1/202 (0.50%)  32/435 (7.36%)  27/161 (16.77%)  59/596 (9.90%) 
Chills * 1  9/202 (4.46%)  35/435 (8.05%)  22/161 (13.66%)  57/596 (9.56%) 
Fatigue * 1  26/202 (12.87%)  81/435 (18.62%)  35/161 (21.74%)  116/596 (19.46%) 
Influenza like illness * 1  47/202 (23.27%)  31/435 (7.13%)  13/161 (8.07%)  44/596 (7.38%) 
Injection site erythema * 1  28/202 (13.86%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Injection site reaction * 1  13/202 (6.44%)  0/435 (0.00%)  0/161 (0.00%)  0/596 (0.00%) 
Oedema peripheral * 1  4/202 (1.98%)  26/435 (5.98%)  12/161 (7.45%)  38/596 (6.38%) 
Pain * 1  7/202 (3.47%)  35/435 (8.05%)  16/161 (9.94%)  51/596 (8.56%) 
Pyrexia * 1  18/202 (8.91%)  94/435 (21.61%)  47/161 (29.19%)  141/596 (23.66%) 
Infections and infestations         
Bronchitis * 1  10/202 (4.95%)  34/435 (7.82%)  15/161 (9.32%)  49/596 (8.22%) 
Gastroenteritis * 1  5/202 (2.48%)  20/435 (4.60%)  9/161 (5.59%)  29/596 (4.87%) 
Gastroenteritis viral * 1  12/202 (5.94%)  17/435 (3.91%)  8/161 (4.97%)  25/596 (4.19%) 
Herpes zoster * 1  3/202 (1.49%)  24/435 (5.52%)  12/161 (7.45%)  36/596 (6.04%) 
Influenza * 1  11/202 (5.45%)  40/435 (9.20%)  18/161 (11.18%)  58/596 (9.73%) 
Nasopharyngitis * 1  48/202 (23.76%)  128/435 (29.43%)  52/161 (32.30%)  180/596 (30.20%) 
Oral herpes * 1  4/202 (1.98%)  35/435 (8.05%)  9/161 (5.59%)  44/596 (7.38%) 
Pharyngitis * 1  1/202 (0.50%)  19/435 (4.37%)  9/161 (5.59%)  28/596 (4.70%) 
Sinusitis * 1  20/202 (9.90%)  58/435 (13.33%)  20/161 (12.42%)  78/596 (13.09%) 
Upper respiratory tract infection * 1  25/202 (12.38%)  70/435 (16.09%)  34/161 (21.12%)  104/596 (17.45%) 
Urinary tract infection * 1  23/202 (11.39%)  92/435 (21.15%)  37/161 (22.98%)  129/596 (21.64%) 
Injury, poisoning and procedural complications         
Contusion * 1  15/202 (7.43%)  50/435 (11.49%)  30/161 (18.63%)  80/596 (13.42%) 
Fall * 1  11/202 (5.45%)  28/435 (6.44%)  10/161 (6.21%)  38/596 (6.38%) 
Investigations         
Bacterial test positive * 1  4/202 (1.98%)  13/435 (2.99%)  9/161 (5.59%)  22/596 (3.69%) 
CD4 lymphocytes decreased * 1  2/202 (0.99%)  23/435 (5.29%)  9/161 (5.59%)  32/596 (5.37%) 
CD8 lymphocytes decreased * 1  4/202 (1.98%)  23/435 (5.29%)  7/161 (4.35%)  30/596 (5.03%) 
Lymphocyte count decreased * 1  5/202 (2.48%)  18/435 (4.14%)  11/161 (6.83%)  29/596 (4.87%) 
Platelet count decreased * 1  12/202 (5.94%)  16/435 (3.68%)  1/161 (0.62%)  17/596 (2.85%) 
T-lymphocyte count decreased * 1  5/202 (2.48%)  16/435 (3.68%)  10/161 (6.21%)  26/596 (4.36%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  25/202 (12.38%)  57/435 (13.10%)  26/161 (16.15%)  83/596 (13.93%) 
Back pain * 1  18/202 (8.91%)  52/435 (11.95%)  30/161 (18.63%)  82/596 (13.76%) 
Muscle spasms * 1  15/202 (7.43%)  28/435 (6.44%)  12/161 (7.45%)  40/596 (6.71%) 
Muscular weakness * 1  14/202 (6.93%)  29/435 (6.67%)  15/161 (9.32%)  44/596 (7.38%) 
Myalgia * 1  13/202 (6.44%)  34/435 (7.82%)  24/161 (14.91%)  58/596 (9.73%) 
Pain in extremity * 1  20/202 (9.90%)  65/435 (14.94%)  26/161 (16.15%)  91/596 (15.27%) 
Nervous system disorders         
Dizziness * 1  11/202 (5.45%)  48/435 (11.03%)  26/161 (16.15%)  74/596 (12.42%) 
Dysgeusia * 1  8/202 (3.96%)  29/435 (6.67%)  14/161 (8.70%)  43/596 (7.21%) 
Headache * 1  35/202 (17.33%)  230/435 (52.87%)  101/161 (62.73%)  331/596 (55.54%) 
Hypoaesthesia * 1  16/202 (7.92%)  35/435 (8.05%)  19/161 (11.80%)  54/596 (9.06%) 
Migraine * 1  11/202 (5.45%)  11/435 (2.53%)  6/161 (3.73%)  17/596 (2.85%) 
Multiple sclerosis relapse * 1  84/202 (41.58%)  119/435 (27.36%)  51/161 (31.68%)  170/596 (28.52%) 
Paraesthesia * 1  20/202 (9.90%)  50/435 (11.49%)  18/161 (11.18%)  68/596 (11.41%) 
Tremor * 1  3/202 (1.49%)  14/435 (3.22%)  10/161 (6.21%)  24/596 (4.03%) 
Psychiatric disorders         
Anxiety * 1  14/202 (6.93%)  31/435 (7.13%)  16/161 (9.94%)  47/596 (7.89%) 
Depression * 1  25/202 (12.38%)  29/435 (6.67%)  16/161 (9.94%)  45/596 (7.55%) 
Insomnia * 1  28/202 (13.86%)  69/435 (15.86%)  32/161 (19.88%)  101/596 (16.95%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  6/202 (2.97%)  35/435 (8.05%)  22/161 (13.66%)  57/596 (9.56%) 
Dyspnoea * 1  1/202 (0.50%)  37/435 (8.51%)  27/161 (16.77%)  64/596 (10.74%) 
Epistaxis * 1  3/202 (1.49%)  23/435 (5.29%)  7/161 (4.35%)  30/596 (5.03%) 
Oropharyngeal pain * 1  10/202 (4.95%)  47/435 (10.80%)  24/161 (14.91%)  71/596 (11.91%) 
Wheezing * 1  2/202 (0.99%)  4/435 (0.92%)  9/161 (5.59%)  13/596 (2.18%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  5/202 (2.48%)  12/435 (2.76%)  10/161 (6.21%)  22/596 (3.69%) 
Erythema * 1  3/202 (1.49%)  23/435 (5.29%)  12/161 (7.45%)  35/596 (5.87%) 
Pruritus * 1  5/202 (2.48%)  66/435 (15.17%)  35/161 (21.74%)  101/596 (16.95%) 
Rash * 1  11/202 (5.45%)  193/435 (44.37%)  95/161 (59.01%)  288/596 (48.32%) 
Rash generalised * 1  2/202 (0.99%)  33/435 (7.59%)  16/161 (9.94%)  49/596 (8.22%) 
Rash pruritic * 1  0/202 (0.00%)  9/435 (2.07%)  11/161 (6.83%)  20/596 (3.36%) 
Urticaria * 1  2/202 (0.99%)  74/435 (17.01%)  42/161 (26.09%)  116/596 (19.46%) 
Vascular disorders         
Flushing * 1  7/202 (3.47%)  34/435 (7.82%)  16/161 (9.94%)  50/596 (8.39%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Efficacy analysis was not performed for Alemtuzumab 24 mg as recruitment to this arm was closed early to reduce overall sample size, duration of enrollment period, overall duration of study.
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.
PI can publish after sponsor published, after a defined period of time after study completion, and/or with written Sponsor approval. Generally PI gives sponsor a draft 60 days before publication. Sponsor can ask that confidential information can be removed, and can further defer publication upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00548405     History of Changes
Other Study ID Numbers: CAMMS32400507
2007-001162-32 ( EudraCT Number )
CAMMS324,
ISRCTN70702834 ( Registry Identifier: ISRCTN )
ACTRN12608000426381 ( Registry Identifier: ANZCTR )
NTR1469 ( Registry Identifier: The Netherlands National Trial Register )
CARE-MS II ( Other Identifier: NMSS )
First Submitted: October 22, 2007
First Posted: October 24, 2007
Results First Submitted: November 17, 2014
Results First Posted: January 8, 2015
Last Update Posted: April 17, 2017