Safety and Efficacy Study of Daclizumab High Yield Process to Treat Relapsing-Remitting Multiple Sclerosis (SELECT)

Inclusion Criteria:

• MS subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline EDSS (Expanded Disability Status Scale) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria

  • Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial MRI demonstrating lesion(s) consistent with MS , OR
  • Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.

Exclusion Criteria:

• Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
• History of malignancy
• History of severe allergic or anaphylactic reactions or known drug hypersensitivity
• History of abnormal laboratory results
• History of human immunodeficiency virus (HIV) or other immunodeficient conditions
• History of drug or alcohol abuse ithin the 2 years prior to randomization
• An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
• Positive screening for active infection with Hepatitis B virus or Hepatitis C virus
• Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening
• Exposure to varicella zoster virus within 21 days before Screening.
• Abnormal blood tests at Screening; Hemoglobin ≤9.0 g/dL, Platelets ≤100 × 109/L, Lymphocytes ≤1.0 × 109/L, Neutrophils ≤1.5 × 109/L, alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase >2 times the upper limit of normal (ULN) and serum creatinine >ULN.