Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab

Exclusion Criteria

• •Current participation in another investigational study.
• •Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold) \[Lublin 2014\].
• •Females breastfeeding, pregnant, or planning to become pregnant; or women who have a positive pregnancy test result during screening.
• •History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to screening.
• •History of severe hypersensitivity (e.g., anaphylaxis or anaphylactoid reactions) to the active ingredient or any of the excipients.
• •History of severe opportunistic infections (including progressive multifocal leukoencephalopathy (PML)) or any clinically significant, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
• •Discontinued natalizumab due to suspicion of PML.
• •Known active malignancies (participants with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
• •The participant is using another MS therapy concomitantly.
• •Known history of human immunodeficiency virus (HIV).
• •Positive test result for Hepatitis C virus (test for hepatitis C virus antibody \[HCV Ab\]) or hepatitis B virus (test for hepatitis B surface antigen \[HBsAg\] and/or hepatitis B core antibody \[HBcAb\]).
• •The participant has been treated with immunosuppressive or immunomodulating treatments including mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil.