An Immunogenicity and Pharmacokinetics (PK) Study of DAC HYP Prefilled Syringe in Relapsing Remitting Multiple Sclerosis (RRMS) (OBSERVE)

Inclusion Criteria:

Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of registration:

• Aged 18 to 65 years old, inclusive, at the time of informed cosnent
• Must have a confirmed diagnosis of RRMS according to McDonald criteria and previous MRI showing lesion
• Must have a baseline EDSS between 0.0 and 5.0, inclusive
• Must have had 1 or more clinical relapses within the previous 2 years
• Women of child bearing potential must be willing to practice effective contraception during the study and 4 monthsh after the last dose

Exclusion Criteria:

Unless otherwise specified, candidates will be excluede from study entry if any of the following exclusion criteria exsist at the time of registration:

• Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease
• Female subjects who are currently pregnant or breastfeeding

Inclusion criteria for the TP-DI Substudy:

To be eligible for participation in the TP-DI Sub-Study, subjects must meet the following eligibility criteria at the Screening Visit at Week 40:

-Must have been compliant with the 205MS302 protocol during the initial 24-week treatment period and through Week 40 of the 20- week washout period in the opinion of the Investigator.

• Must agree to resume DAC HYP treatment 12 weeks after completion of the washout period (i.e., 12 weeks after their Week 44 visit).
• Must have normal LFT results (total bilirubin ≤1.5 × ULN, ALT/AST ≤2 × ULN, and prothrombin time/partial thromboplastin time ≤1.2 × ULN).
• Must have normal renal function as estimated creatinine clearance >60 mL/min (Cockcroft-Gault formula).

Other protocol-defined inclusion/exclusion criteria will apply for the 3 year extension study and the TP-DI substudy as per protocol version 4 dated 28 Sep 2012, section 8.