A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

Exclusion Criteria

• •Previous immunotherapy for MS other than steroids, including treatment with interferons, intravenous immunoglobulin (IVIG), glatiramer acetate, and mitoxantrone
• •Personal history of thyroid autoimmune disease
• •Personal history of clinically significant autoimmune disease (for example, inflammatory bowel disease, diabetes, lupus, severe asthma)
• •History of thyroid carcinoma (previous thyroid adenoma was acceptable and was not considered an exclusion criterion)
• •History of malignancy (except for basal cell skin carcinoma if disease-free for at least 5 years)
• •Any disability acquired from trauma or another illness that, in the opinion of the Investigator, interfered with evaluation of disability due to MS
• •Previous treatment with alemtuzumab
• •History of anaphylaxis following exposure to humanized monoclonal antibodies
• •Inability to undergo MRI with gadolinium administration
• •Female participants of childbearing potential with a positive serum pregnancy test at screening or Baseline
• •Male and female participants who did not agree to use effective contraceptive method(s) during the study
• •Impaired renal function (that is, serum creatinine greater than or equal to 2 times the upper limit of normal \[ULN\])
• •Untreated, major depressive disorder
• •Epileptic seizures that were not adequately controlled by treatment
• •Suicidal ideation
• •Major systemic disease or other illness that, in the opinion of the Investigator, have compromised participant safety or interfered with the interpretation of study results
• •Abnormal CD4 count or significantly abnormal thyroid function; presence of anti-thyroid stimulating hormone (TSH) receptor antibodies; known seropositivity for human immunodeficiency (HIV)
• •Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
• •Presence of a monoclonal paraprotein
• •Participants who had any form of MS other than relapsing-remitting
• •Participants currently participating in a clinical study of an experimental or unapproved/unlicensed therapy