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A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
This study is ongoing, but not recruiting participants.
Study NCT00050778   Information provided by Genzyme
First Received: December 19, 2002   Last Updated: July 13, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Condition: Multiple Sclerosis, Relapsing-Remitting
Interventions: Biological: interferon beta-1a (Rebif®)
Biological: alemtuzumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm/Group 1: Interferon Beta-1a (Rebif®) 44 micrograms (mcg) administered 3-times weekly by subcutaneous (SC) injections for 36 months
Arm/Group 2: 12 mg Alemtuzumab 12 milligrams (mg) per day administered through intravenous (IV) infusion, once a day for 5 consecutive days at Month 0 and 12 mg per day administered through IV, once a day for 3 consecutive days at Month 12; optional re-treatment at Month 24 depending on investigator discretion and laboratory assessments.
Arm/Group 3: 24 mg Alemtuzumab 24 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 24 mg per day administered through IV, once a day for 3 consecutive days at Month 12; optional re-treatment at Month 24 depending on investigator discretion and laboratory assessments.

Participant Flow:   Overall Study
  Arm/Group 1: Interferon Beta-1a (Rebif®) Arm/Group 2: 12 mg Alemtuzumab Arm/Group 3: 24 mg Alemtuzumab
STARTED   111     113[1]   110  
COMPLETED   66     92     92  
NOT COMPLETED   45     21     18  
      Adverse Event               13                 2                 1  
      Death               0                 1                 1  
      Lack of Efficacy               16                 2                 2  
      Lost to Follow-up               0                 2                 4  
      Physician Decision               3                 1                 2  
      Protocol Violation               2                 0                 1  
      Withdrawal by Subject               3                 0                 2  
      Not Dosed Due to Depression               1                 0                 0  
      Noncompliant               4                 8                 4  
      Not Dosed Due to Thyroid Abnormality               0                 3                 0  
      Not Dosed Due to Randomization Error               0                 2                 0  
      Other Reason               3                 0                 1  
[1] 1 patient included in safety but excluded from efficacy analysis; initial MS diagnosis was incorrect



  Baseline Characteristics
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Reporting Groups
  Description
Arm/Group 1: Interferon Beta-1a (Rebif®) 44 micrograms (mcg) administered 3-times weekly by subcutaneous (SC) injections for 36 months
Arm/Group 2: 12 mg Alemtuzumab 12 milligrams (mg) per day administered through intravenous (IV) infusion, once a day for 5 consecutive days at Month 0 and 12 mg per day administered through IV, once a day for 3 consecutive days at Month 12; optional re-treatment at Month 24 depending on investigator discretion and laboratory assessments.
Arm/Group 3: 24 mg Alemtuzumab 24 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 24 mg per day administered through IV, once a day for 3 consecutive days at Month 12; optional re-treatment at Month 24 depending on investigator discretion and laboratory assessments.

Baseline Measures
  Arm/Group 1: Interferon Beta-1a (Rebif®) Arm/Group 2: 12 mg Alemtuzumab Arm/Group 3: 24 mg Alemtuzumab Total
Number of Participants  
[units: participants]
 		111 112 110 333
Age  
[units: years]
Mean ± Standard Deviation 		32.8 ± 8.8 31.9 ± 8.0 32.2 ± 8.8 32.3 ± 8.5
Gender, Customized  
[units: Number of Participants]
 		       
Male 40 40 39 119
Female 71 72 71 214



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sustained Accumulation of Disability (SAD), Confirmed Through 6 Months   [ 3 years ]
  Show Outcome Measure 1

2.  Primary:   Relapse   [ 3 years ]
  Show Outcome Measure 2


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Arm 1: Interferon Beta-1a (Rebif) 44 mcg administered 3-times weekly by SC injections for 36 months
Arm 2: 12 mg Alemtuzumab 12 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 12 mg per day administered through IV, once a day for 3 consecutive days at Month 12; optional re-treatment at Month 24 depending on investigator discretion and laboratory assessments.
Arm 3: 24 mg Alemtuzumab 24 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 24 mg per day administered through IV, once a day for 3 consecutive days at Month 12; optional re-treatment at Month 24 depending on investigator discretion and laboratory assessments.
Alemtuzumab Arms (Arms 2 and 3) Pooled All patients receiving alemtuzumab.

Serious Adverse Events
  Arm 1: Interferon Beta-1a (Rebif) Arm 2: 12 mg Alemtuzumab Arm 3: 24 mg Alemtuzumab Alemtuzumab Arms (Arms 2 and 3) Pooled
Total, serious adverse events        
# participants affected 24   24   27   51  
Blood and lymphatic system disorders        
Autoimmune thrombocytopenia   † A
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
2/108 (1.85%)
2  
3/216 (1.39%)
3  
Idiopathic thrombocytopenic purpura   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Thrombocytopenia   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Cardiac disorders        
Acute myocardial infarction   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Bradycardia   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Cardiovascular disorder   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Arrhythmia   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Myocardial infarction   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Ear and labyrinth disorders        
Deafness   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Endocrine disorders        
Hyperthyroidism   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
2/108 (1.85%)
2  
3/216 (1.39%)
3  
Eye disorders        
Extraocular muscle disorder   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Optic atrophy   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Diplopia   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Gastrointestinal disorders        
Abdominal hernia   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Dental necrosis   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Dyspepsia   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Erosive oesophagitis   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Gastritis   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Gastroduodenitis   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Ileus   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Nausea   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Peritonitis   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Salivary gland calculus   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Vomiting   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
2  
1/216 (0.46%)
2  
Enterocutaneous fistula   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Hypoaesthesia oral   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Paraesthesia oral   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
General disorders        
Adverse drug reaction   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Chest discomfort   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
2  
1/216 (0.46%)
2  
Chest pain   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
3  
1/216 (0.46%)
3  
Infusion related reaction   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Pyrexia   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Fatigue   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Gait disturbance   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
2  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Hepatobiliary disorders        
Hepatic failure   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Infections and infestations        
Gastroenteritis   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
1/108 (0.93%)
1  
2/216 (0.93%)
2  
Bronchitis   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Cellulitis of male external genital organ   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Cervicitis   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Meningitis listeria   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Meningitis viral   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Urinary tract infection   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Varicella   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Appendicitis   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Central line infection   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Injury, poisoning and procedural complications        
Drug toxicity   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Limb traumatic amputation   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Alcohol poisoning   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Fibula fracture   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Tibia fracture   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Investigations        
Aspartate aminotransferase increased   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Transaminases increased   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Hepatic enzyme increased   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Metabolism and nutrition disorders        
Hypokalaemia   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Dehydration   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Musculoskeletal and connective tissue disorders        
Arthritis   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Back pain   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Muscle spasms   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Muscular weakness   † B
      # participants affected / at risk
      # events
4/107 (3.74%)
6  
0/108 (0.00%)
0  
1/108 (0.93%)
2  
1/216 (0.46%)
2  
Pain in extremity   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
2  
1/216 (0.46%)
2  
Intervertebral disc protrusion   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Osteoarthritis   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Breast cancer   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Cervix carcinoma   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Uterine leiomyoma   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Colon cancer   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Burkitt’s lymphoma   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Nervous system disorders        
Multiple sclerosis relapse   † B
      # participants affected / at risk
      # events
5/107 (4.67%)
12  
4/108 (3.70%)
12  
3/108 (2.78%)
3  
7/216 (3.24%)
15  
Paraparesis   † B
      # participants affected / at risk
      # events
3/107 (2.80%)
3  
1/108 (0.93%)
1  
2/108 (1.85%)
3  
3/216 (1.39%)
4  
Hemiparesis   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
1/108 (0.93%)
1  
1/108 (0.93%)
1  
2/216 (0.93%)
2  
Nystagmus   † B
      # participants affected / at risk
      # events
2/107 (1.87%)
2  
1/108 (0.93%)
1  
1/108 (0.93%)
1  
2/216 (0.93%)
2  
Balance disorder   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Cerebellar ataxia   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Cerebral haemorrhage   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Cerebrovascular accident   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Coordination abnormal   † B
      # participants affected / at risk
      # events
5/107 (4.67%)
7  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Facial palsy   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Headache   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Hypoaesthesia   † B
      # participants affected / at risk
      # events
2/107 (1.87%)
5  
0/108 (0.00%)
0  
1/108 (0.93%)
2  
1/216 (0.46%)
2  
Multiple sclerosis   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
5  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Myelitis transverse   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Syncope   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Tremor   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Dizziness   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Dysaesthesia   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Dysarthria   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Facial paresis   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Monoparesis   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
2  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Paraesthesia   † B
      # participants affected / at risk
      # events
3/107 (2.80%)
6  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Sensory disturbance   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Sensory loss   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Pregnancy, puerperium and perinatal conditions        
Abortion spontaneous   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Abortion threatened   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Psychiatric disorders        
Bipolar disorder   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Depression   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Anxiety   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Renal and urinary disorders        
Urinary incontinence   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
2/108 (1.85%)
2  
2/216 (0.93%)
2  
Bladder spasm   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Dysuria   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Nephrolithiasis   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Urinary retention   † B
      # participants affected / at risk
      # events
2/107 (1.87%)
2  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Reproductive system and breast disorders        
Dysmenorrhoea   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Metrorrhagia   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Ovarian cyst   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Endometriosis   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Menorrhagia   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Ovarian cyst ruptured   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Pelvic pain   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Respiratory, thoracic and mediastinal disorders        
Asthma   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
2/108 (1.85%)
5  
2/216 (0.93%)
5  
Pulmonary embolism   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Wheezing   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Social circumstances        
Miscarriage of partner   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
0/108 (0.00%)
0  
1/108 (0.93%)
1  
1/216 (0.46%)
1  
Surgical and medical procedures        
Jaw operation   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
Carpal tunnel decompression   † B
      # participants affected / at risk
      # events
1/107 (0.93%)
1  
0/108 (0.00%)
0  
0/108 (0.00%)
0  
0/216 (0.00%)
0  
Vascular disorders        
Hypertension   † B
      # participants affected / at risk
      # events
0/107 (0.00%)
0  
1/108 (0.93%)
1  
0/108 (0.00%)
0  
1/216 (0.46%)
1  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA SOC
B Term from vocabulary, MedDRA


  Other Adverse Events
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
phone: 800-745-4447


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

Other Publications:
Coles AJ, Cox A, Le Page E, Jones J, Trip SA, Deans J, Seaman S, Miller DH, Hale G, Waldmann H, Compston DA. The window of therapeutic opportunity in multiple sclerosis: evidence from monoclonal antibody therapy. J Neurol. 2006 Jan;253(1):98-108. Epub 2005 Jul 27.


Responsible Party: Genzyme Corporation ( Medical Monitor )
Study ID Numbers: CAMMS223
Study First Received: December 19, 2002
Results First Received: November 3, 2008
Last Updated: July 13, 2009
ClinicalTrials.gov Identifier: NCT00050778     History of Changes
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Croatia: Ministry of Health and Social Care;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   Russia: Ministry of Health and Social Development of the Russian Federation





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