A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon β-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase

INTERVENTION: Product Name: Fingolimod Product Code: FTY720 Pharmaceutical Form: Capsule* INN or Proposed INN: Fingolimod CAS Number: 162359‐56‐0 Current Sponsor code: FTY720 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5, 1.25‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Avonex Product Name: Interferon beta‐1a Pharmaceutical Form: Solution for injection INN or Proposed INN: interferon beta‐1a Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 30/0.5‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use CONDITION: Relapsing‐remitting multiple sclerosis (RRMS) PRIMARY OUTCOME: Main Objective: The primary objective is to compare fingolimod 1.25 mg and 0.5 mg with interferon ß‐1a and to demonstrate that at least 1.25 mg fingolimod is superior to interferon ß‐1a in terms of annualized relapse rate for patients with RRMS treated for up to 12 months. Primary end point(s): The primary endpoint will be the annualized relapse rate (ARR), which is defined as the number of relapses in a year.; ; The key secondary endpoint will be the proportion of relapse‐free patients.; ; Other secondary endpoints include: ; • time to first relapse; • time to second relapse; • number of hospitalizations due to relapses; • frequency of corticosteroid use to treat relapses; • time to confirmed disability progression; • proportion of patients with confirmed disability progression; • change from Baseline to the end of study on the MSFC z‐score; • Burden of disease as measured by MRI:; • % change from baseline in volume of T2 lesions at 12 months; • % change from baseline in volume of T1 hypointense lesions at 12 months; • Inflammatory disease activity as measured by MRI:; • proportion of scans showing Gd‐enhanced T1 lesions; • proportion of scans showing new/ newly enlarged T2 lesions; • number of new/ newly enlarged T2 lesions; • number of Gd‐enhanced T1 lesions; • volume of Gd‐enhanced T1 lesions; • proportion of scans free of new inflammatory activity (Gd‐enhanced lesions or; new/ newly enlarged T2 lesions) Secondary Objective: Key secondary objectives: ; ; To demonstrate superiority of fingolimod 1.25 mg and 0.5 mg over interferon ß‐1a in patients with RRMS treated for up to 12 months with respect to: ; 1. The effect on inflammatory disease activity as measured by number new/ newly enlarging T2 lesions after up to 12 months of treatment. ; 2. The effect on disability progression as measured by the time to 3‐month confirmed disability progression as measured by EDSS. INCLUSION CRITERIA: General 1. male or female; Females of childbearing potential must: • have negative pregnancy tests prior to entry into the Double‐Blind Treatment Phase • use simultaneously two forms of effective contraception (either partner) during the treatment and for 3 months after discontinuation of the study medication (Refer to Section 7.5.9 for more details). Females that are either post‐menopausal for 12 months prior to Randomization or are surgically sterile (through hysterectomy or bilateral oophorectomy) are not required to use birth control 2. 18 through 55 years of age inclusive 3. sign written informed consent prior to participating in the study (Appendix 1). Multiple sclerosis 4. diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria (Appendix 3) 5. a relapsing‐remitting course with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years; prior to randomizati