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

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ClinicalTrials.gov Identifier: NCT00530348
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : November 24, 2014
Last Update Posted : November 24, 2014
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
Biological: Interferon beta-1a
Enrollment 581
Recruitment Details Participants were screened at 101 investigational sites in Argentina, Australia, Brazil, Canada, Croatia, the Czech Republic, France, Germany, Mexico, Poland, Russia, Serbia, Sweden, Ukraine, the United Kingdom (UK), and the United States (US) between August 28, 2007 and April 27, 2011.
Pre-assignment Details  
Arm/Group Title Interferon Beta-1a Alemtuzumab
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.
Period Title: Overall Study
Started 195 [1] 386 [1]
Treated 187 [2] 376 [2]
Completed 173 367
Not Completed 22 19
Reason Not Completed
Adverse Event             5             1
Death             0             1
Lack of Efficacy             2             0
Lost to Follow-up             0             2
Physician Decision             1             2
Pregnancy             1             0
Withdrawal by Subject             12             12
Randomised in error             1             0
Noncompliance with inclusion criterion 3             0             1
[1]
Randomized.
[2]
All randomized participants who received at least 1 dose of study drug.
Arm/Group Title Interferon Beta-1a Alemtuzumab 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 on 3 consecutive days at Month 12. Total of all reporting groups
Overall Number of Baseline Participants 187 376 563
Hide Baseline Analysis Population Description
Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 187 participants 376 participants 563 participants
33.2  (8.48) 33.0  (8.03) 33.1  (8.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 376 participants 563 participants
Female
122
  65.2%
243
  64.6%
365
  64.8%
Male
65
  34.8%
133
  35.4%
198
  35.2%
Time Since First Relapse  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 187 participants 376 participants 563 participants
2.0  (1.32) 2.1  (1.36) 2.1  (1.35)
Number of Relapse Episodes in the Preceding 2 Years   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 187 participants 376 participants 563 participants
1 Relapse 3 12 15
2 Relapses 118 215 333
Greater than or equal to 3 Relapses 66 149 215
[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 187 participants 376 participants 563 participants
2.0  (0.79) 2.0  (0.81) 2.0  (0.81)
[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 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: 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 next 2 scheduled assessments, that is, 6 consecutive months. 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.
Arm/Group Title Interferon Beta-1a Alemtuzumab
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 187 376
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants with SAD
11.12
(7.32 to 16.71)
8.00
(5.66 to 11.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab
Comments Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariates was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2173
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 0.70
Confidence Interval (2-Sided) 95%
0.40 to 1.23
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 included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Interferon Beta-1a Alemtuzumab
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 187 376
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: relapses per participant per year
0.39
(0.29 to 0.53)
0.18
(0.13 to 0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab
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 0.45
Confidence Interval (2-Sided) 95%
0.32 to 0.63
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 included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Interferon Beta-1a Alemtuzumab
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 187 376
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
58.69
(51.12 to 65.50)
77.59
(72.87 to 81.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab
Comments Cox PH regression model with robust variance estimation, covariate adjustment for geographic region, was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.
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 0.45
Confidence Interval (2-Sided) 95%
0.33 to 0.61
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 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). 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 included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2).
Arm/Group Title Interferon Beta-1a Alemtuzumab
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 173 366
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (1.05) -0.2  (0.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab
Comments The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4188
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 included all randomized participants who received at least 1 dose of study drug. 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).
Arm/Group Title Interferon Beta-1a Alemtuzumab
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 186 375
Mean (Standard Deviation)
Unit of Measure: Z-score
Baseline (n=186, 375) 0.05  (0.629) -0.02  (0.695)
Change at Year 2 (n=172, 362) 0.07  (0.450) 0.15  (0.516)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab
Comments Change at Year 2: analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by MSFC. Each endpoint could only be formally tested if prior endpoint was significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0115
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 included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2).
Arm/Group Title Interferon Beta-1a Alemtuzumab
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 177 364
Mean (Standard Deviation)
Unit of Measure: percent change
-6.68  (32.44) -10.28  (22.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon Beta-1a, Alemtuzumab
Comments Ranked ANCOVA models with covariate adjustment for geographic region and baseline T2 lesion volume was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3080
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 both a serious and a non-serious event with the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. The analysis was performed on the safety population, defined as all participants who received any amount of study drug.
 
Arm/Group Title Interferon Beta-1a Alemtuzumab
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.
All-Cause Mortality
Interferon Beta-1a Alemtuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Interferon Beta-1a Alemtuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   27/187 (14.44%)   69/376 (18.35%) 
Blood and lymphatic system disorders     
Agranulocytosis * 1  0/187 (0.00%)  2/376 (0.53%) 
Autoimmune thrombocytopenia * 1  0/187 (0.00%)  3/376 (0.80%) 
Cardiac disorders     
Atrial fibrillation * 1  0/187 (0.00%)  2/376 (0.53%) 
Bradycardia * 1  0/187 (0.00%)  1/376 (0.27%) 
Sinus bradycardia * 1  0/187 (0.00%)  1/376 (0.27%) 
Sinus tachycardia * 1  0/187 (0.00%)  2/376 (0.53%) 
Tachycardia * 1  0/187 (0.00%)  1/376 (0.27%) 
Endocrine disorders     
Basedow's disease * 1  0/187 (0.00%)  2/376 (0.53%) 
Goitre * 1  0/187 (0.00%)  1/376 (0.27%) 
Hyperthyroidism * 1  0/187 (0.00%)  1/376 (0.27%) 
Thyrotoxic crisis * 1  0/187 (0.00%)  1/376 (0.27%) 
Gastrointestinal disorders     
Colitis * 1  1/187 (0.53%)  0/376 (0.00%) 
Malocclusion * 1  1/187 (0.53%)  0/376 (0.00%) 
Nausea * 1  0/187 (0.00%)  1/376 (0.27%) 
Oesophagitis * 1  1/187 (0.53%)  0/376 (0.00%) 
General disorders     
Chest discomfort * 1  0/187 (0.00%)  1/376 (0.27%) 
Non-cardiac chest pain * 1  1/187 (0.53%)  0/376 (0.00%) 
Pyrexia * 1  0/187 (0.00%)  1/376 (0.27%) 
Hepatobiliary disorders     
Hepatitis toxic * 1  1/187 (0.53%)  0/376 (0.00%) 
Immune system disorders     
Anaphylactic shock * 1  0/187 (0.00%)  1/376 (0.27%) 
Infections and infestations     
Appendicitis * 1  1/187 (0.53%)  2/376 (0.53%) 
Disseminated tuberculosis * 1  0/187 (0.00%)  1/376 (0.27%) 
Hepatitis A * 1  1/187 (0.53%)  0/376 (0.00%) 
Herpes zoster * 1  0/187 (0.00%)  1/376 (0.27%) 
Meningitis herpes * 1  0/187 (0.00%)  1/376 (0.27%) 
Postoperative wound infection * 1  0/187 (0.00%)  1/376 (0.27%) 
Tooth infection * 1  0/187 (0.00%)  1/376 (0.27%) 
Uterine infection * 1  0/187 (0.00%)  1/376 (0.27%) 
Injury, poisoning and procedural complications     
Abdominal wound dehiscence * 1  0/187 (0.00%)  1/376 (0.27%) 
Accidental overdose * 1  1/187 (0.53%)  0/376 (0.00%) 
Foot fracture * 1  0/187 (0.00%)  2/376 (0.53%) 
Forearm fracture * 1  1/187 (0.53%)  0/376 (0.00%) 
Hand fracture * 1  1/187 (0.53%)  0/376 (0.00%) 
Humerus fracture * 1  1/187 (0.53%)  0/376 (0.00%) 
Incorrect dose administered * 1  0/187 (0.00%)  2/376 (0.53%) 
Joint dislocation * 1  0/187 (0.00%)  1/376 (0.27%) 
Post procedural haemorrhage * 1  1/187 (0.53%)  0/376 (0.00%) 
Road traffic accident * 1  0/187 (0.00%)  1/376 (0.27%) 
Skin laceration * 1  0/187 (0.00%)  1/376 (0.27%) 
Investigations     
Thyroxine free increased * 1  0/187 (0.00%)  1/376 (0.27%) 
Tri-iodothyronine free increased * 1  0/187 (0.00%)  1/376 (0.27%) 
Metabolism and nutrition disorders     
Feeding disorder neonatal * 1  0/187 (0.00%)  1/376 (0.27%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  0/187 (0.00%)  1/376 (0.27%) 
Osteitis * 1  1/187 (0.53%)  0/376 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder papilloma * 1  0/187 (0.00%)  1/376 (0.27%) 
Thyroid cancer * 1  0/187 (0.00%)  2/376 (0.53%) 
Uterine leiomyoma * 1  0/187 (0.00%)  1/376 (0.27%) 
Nervous system disorders     
Brain stem syndrome * 1  0/187 (0.00%)  1/376 (0.27%) 
Cerebrovascular insufficiency * 1  0/187 (0.00%)  1/376 (0.27%) 
Headache * 1  0/187 (0.00%)  2/376 (0.53%) 
Hypoxic-ischaemic encephalopathy * 1  0/187 (0.00%)  1/376 (0.27%) 
Migraine * 1  0/187 (0.00%)  1/376 (0.27%) 
Multiple sclerosis * 1  0/187 (0.00%)  1/376 (0.27%) 
Multiple sclerosis relapse * 1  13/187 (6.95%)  19/376 (5.05%) 
Syncope * 1  0/187 (0.00%)  2/376 (0.53%) 
Psychiatric disorders     
Insomnia * 1  0/187 (0.00%)  1/376 (0.27%) 
Major depression * 1  0/187 (0.00%)  1/376 (0.27%) 
Mood altered * 1  1/187 (0.53%)  0/376 (0.00%) 
Suicide attempt * 1  0/187 (0.00%)  1/376 (0.27%) 
Renal and urinary disorders     
Nephrolithiasis * 1  0/187 (0.00%)  1/376 (0.27%) 
Reproductive system and breast disorders     
Menometrorrhagia * 1  0/187 (0.00%)  2/376 (0.53%) 
Menorrhagia * 1  0/187 (0.00%)  1/376 (0.27%) 
Ovarian cyst * 1  0/187 (0.00%)  1/376 (0.27%) 
Ovarian haemorrhage * 1  1/187 (0.53%)  0/376 (0.00%) 
Uterine polyp * 1  0/187 (0.00%)  1/376 (0.27%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  1/187 (0.53%)  0/376 (0.00%) 
Pleurisy * 1  0/187 (0.00%)  1/376 (0.27%) 
Pneumonitis * 1  0/187 (0.00%)  1/376 (0.27%) 
Sleep apnoea syndrome * 1  0/187 (0.00%)  1/376 (0.27%) 
Throat tightness * 1  0/187 (0.00%)  1/376 (0.27%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  0/187 (0.00%)  1/376 (0.27%) 
Increased tendency to bruise * 1  0/187 (0.00%)  1/376 (0.27%) 
Urticaria * 1  0/187 (0.00%)  2/376 (0.53%) 
Social circumstances     
Physical assault * 1  0/187 (0.00%)  1/376 (0.27%) 
Vascular disorders     
Hypotension * 1  0/187 (0.00%)  2/376 (0.53%) 
*
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
Affected / at Risk (%) Affected / at Risk (%)
Total   168/187 (89.84%)   360/376 (95.74%) 
Blood and lymphatic system disorders     
Anaemia * 1  11/187 (5.88%)  8/376 (2.13%) 
Leukopenia * 1  10/187 (5.35%)  11/376 (2.93%) 
Lymphopenia * 1  8/187 (4.28%)  26/376 (6.91%) 
Neutropenia * 1  12/187 (6.42%)  7/376 (1.86%) 
Cardiac disorders     
Tachycardia * 1  3/187 (1.60%)  34/376 (9.04%) 
Gastrointestinal disorders     
Abdominal pain * 1  5/187 (2.67%)  21/376 (5.59%) 
Abdominal pain upper * 1  0/187 (0.00%)  22/376 (5.85%) 
Diarrhoea * 1  6/187 (3.21%)  36/376 (9.57%) 
Dyspepsia * 1  8/187 (4.28%)  33/376 (8.78%) 
Nausea * 1  14/187 (7.49%)  65/376 (17.29%) 
Vomiting * 1  4/187 (2.14%)  42/376 (11.17%) 
General disorders     
Chest discomfort * 1  6/187 (3.21%)  25/376 (6.65%) 
Chills * 1  3/187 (1.60%)  38/376 (10.11%) 
Fatigue * 1  23/187 (12.30%)  68/376 (18.09%) 
Influenza like illness * 1  59/187 (31.55%)  19/376 (5.05%) 
Injection site erythema * 1  56/187 (29.95%)  0/376 (0.00%) 
Injection site haematoma * 1  12/187 (6.42%)  1/376 (0.27%) 
Injection site pain * 1  10/187 (5.35%)  0/376 (0.00%) 
Injection site reaction * 1  14/187 (7.49%)  0/376 (0.00%) 
Pain * 1  5/187 (2.67%)  23/376 (6.12%) 
Pyrexia * 1  18/187 (9.63%)  138/376 (36.70%) 
Infections and infestations     
Bronchitis * 1  4/187 (2.14%)  23/376 (6.12%) 
Influenza * 1  11/187 (5.88%)  28/376 (7.45%) 
Nasopharyngitis * 1  25/187 (13.37%)  74/376 (19.68%) 
Oral herpes * 1  2/187 (1.07%)  40/376 (10.64%) 
Rhinitis * 1  6/187 (3.21%)  20/376 (5.32%) 
Sinusitis * 1  9/187 (4.81%)  30/376 (7.98%) 
Upper respiratory tract infection * 1  25/187 (13.37%)  57/376 (15.16%) 
Urinary tract infection * 1  8/187 (4.28%)  64/376 (17.02%) 
Injury, poisoning and procedural complications     
Contusion * 1  11/187 (5.88%)  38/376 (10.11%) 
Investigations     
Alanine aminotransferase increased * 1  19/187 (10.16%)  2/376 (0.53%) 
Aspartate aminotransferase increased * 1  17/187 (9.09%)  3/376 (0.80%) 
B-lymphocyte count decreased * 1  0/187 (0.00%)  19/376 (5.05%) 
Blood urine present * 1  6/187 (3.21%)  20/376 (5.32%) 
CD4 lymphocytes decreased * 1  4/187 (2.14%)  26/376 (6.91%) 
CD8 lymphocytes decreased * 1  5/187 (2.67%)  26/376 (6.91%) 
T-lymphocyte count decreased * 1  5/187 (2.67%)  22/376 (5.85%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  10/187 (5.35%)  41/376 (10.90%) 
Back pain * 1  13/187 (6.95%)  48/376 (12.77%) 
Muscle spasms * 1  6/187 (3.21%)  20/376 (5.32%) 
Muscular weakness * 1  11/187 (5.88%)  29/376 (7.71%) 
Neck pain * 1  2/187 (1.07%)  21/376 (5.59%) 
Pain in extremity * 1  15/187 (8.02%)  35/376 (9.31%) 
Nervous system disorders     
Dizziness * 1  8/187 (4.28%)  33/376 (8.78%) 
Dysgeusia * 1  19/187 (10.16%)  39/376 (10.37%) 
Headache * 1  52/187 (27.81%)  189/376 (50.27%) 
Hypoaesthesia * 1  19/187 (10.16%)  28/376 (7.45%) 
Migraine * 1  11/187 (5.88%)  15/376 (3.99%) 
Multiple sclerosis relapse * 1  64/187 (34.22%)  65/376 (17.29%) 
Paraesthesia * 1  13/187 (6.95%)  32/376 (8.51%) 
Psychiatric disorders     
Anxiety * 1  10/187 (5.35%)  24/376 (6.38%) 
Depression * 1  14/187 (7.49%)  28/376 (7.45%) 
Insomnia * 1  31/187 (16.58%)  56/376 (14.89%) 
Reproductive system and breast disorders     
Menorrhagia * 1  2/187 (1.07%)  24/376 (6.38%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  10/187 (5.35%)  39/376 (10.37%) 
Dyspnoea * 1  4/187 (2.14%)  32/376 (8.51%) 
Oropharyngeal pain * 1  11/187 (5.88%)  42/376 (11.17%) 
Skin and subcutaneous tissue disorders     
Erythema * 1  6/187 (3.21%)  20/376 (5.32%) 
Pruritus * 1  3/187 (1.60%)  52/376 (13.83%) 
Rash * 1  9/187 (4.81%)  174/376 (46.28%) 
Rash generalised * 1  2/187 (1.07%)  28/376 (7.45%) 
Urticaria * 1  5/187 (2.67%)  50/376 (13.30%) 
Vascular disorders     
Flushing * 1  10/187 (5.35%)  44/376 (11.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
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 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: NCT00530348     History of Changes
Other Study ID Numbers: CAMMS323
ISRCTN21534255 ( Registry Identifier: ISRCTN )
ACTRN12608000435381 ( Registry Identifier: ANZCTR )
CARE-MS I ( Other Identifier: NMSS )
2007-001161-14 ( EudraCT Number )
First Submitted: September 13, 2007
First Posted: September 17, 2007
Results First Submitted: November 17, 2014
Results First Posted: November 24, 2014
Last Update Posted: November 24, 2014