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

Inclusion Criteria:

• 1.Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period, andhad not subsequently received disease modifying treatments (other than glatirameracetate or interferon beta); or

• 2.Received Rebif® in CAMMS323 or CAMMS324, completed the 2-year study period, and hadnot subsequently received alternative disease modifying treatments (other thanglatiramer acetate or another interferon beta); or

• 3.Participated in CAMMS223.

• NOTE: Criteria 1 and 2 above meant that participants who enrolled in CAMMS323 orCAMMS324 but did not complete the 2-year study period or went on to receive non-studydrug DMTs after randomization were not eligible for inclusion in the Extension Study.Participants who enrolled in CAMMS324 after participation in CAMMS223 must meetcriteria 1 or 2 to be eligible for inclusion in the Extension Study.

Exclusion Criteria:

• Any alemtuzumab participant from CAMMS223, CAMMS323, or CAMMS324 who had receivedalemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies), orwas participating in any other investigational study, unless approved by Genzyme. Inaddition, these participants must be screened for disqualifying safety concerns beforereceiving alemtuzumab retreatment.

• Any Rebif® participants from CAMMS223, CAMMS323, or CAMMS324 who met any of thefollowing criteria. In addition, these participants must be screened for disqualifyingsafety concerns before receiving alemtuzumab treatment. a) Did not wish to receivealemtuzumab; b) Ongoing participation in any other investigational study, unlessapproved by Genzyme; c) Had received alemtuzumab off-label (ie, outside of one of theprior Genzyme-sponsored studies); d) Known bleeding disorder or therapeuticanticoagulation; e) Diagnosis of idiopathic thrombocytopenia purpura or otherautoimmune hematologic abnormality; f) History of malignancy, except basal cell skincarcinoma; g) Intolerance of pulsed corticosteroids, especially a history of steroidpsychosis h) Significant Autoimmune disorder (other than MS); i) Major psychiatricdisorder or epileptic seizures not adequately controlled by treatment; j) Activeinfection or high risk for infection k) Unwilling to use a reliable and acceptablecontraceptive method during and for at least 6 months following each alemtuzumabtreatment cycle (fertile participants only).