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

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
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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.

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

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