Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)

• Evaluation of Patient Reported Outcomes in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC) [ Time Frame: Experiencing at 6 Months ] [ Designated as safety issue: Yes ]
  The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g., vital signs, ophthalmic and cardiovascular findings) will be summarized, as appropriate.
• Changes in patient-reported effectiveness, side effects and convenience subscales with fingolimod vs. DMT standard of care, using the TSQM v1.4, in patients who have been previously treated for RRMS [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  TSQM v 1.4 subscales for effectiveness, and convenience will be included. The analysis of variable will be similar to the analysis of the primary variable
• Change in patient-reported depression with fingolimod vs. DMT standard of care, using the Beck Depression Inventory (BDI-I), in patients who have been previously treated for RRMS [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

  As BDI-I is brief and not confounded with neurological symptoms, it is recommended for depression evaluation in patients with multiple sclerosis.

  If suicidal ideation is detected by the BDI-I, evaluation and appropriate treatment must be initiated immediately according to the clinical judgment of the investigator or treating physician, and the site must notify the monitor. The event will be reported as an SAE and data will be captured on an electronic Case Report Form (eCRF) identifying the serious adverse event (SAE). The BDI-I will be completed at screening and 3 and 6 months.

• Change in patient-reported health-related quality-of-life with fingolimod vs. DMT standard of care, using the Short Form Health Survey v2 acute (SF-36 v2 acute), in patients who have been previously treated for RRMS [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  The SF-36 is a health-related quality of life instrument used in numerous disease states, including MS (Brazier et al 1992). It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-36v2 acute will be completed at screening and month 6.

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.

• Drug: Fingolimod 0.5 mg/day per os
• Drug: Interferon β- 1a
  Interferon β- 1a 44 mcg subcutaneously three times a week or glatiramer acetate subcutaneously, 20 mg a day

• Experimental: 1
  Intervention: Drug: Fingolimod 0.5 mg/day per os
• Experimental: 2
  Intervention: Drug: Interferon β- 1a

Inclusion Criteria:

• Written informed consent must be obtained before any assessment is performed.
• Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2).
• Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
• Male or female patients aged 18-70 years.
• An Expanded Disability Status Scale (EDSS) score of 0-6 inclusive.
• Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
• Naïve to treatment with fingolimod.

Exclusion Criteria:

• A manifestation of MS other than those defined in the inclusion criteria.
• A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
• History of malignancy of any organ system.
• Diagnosis of macular edema during Screening Phase.
• Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test.
• Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline.
• Patients who have received total lymphoid irradiation or bone marrow transplantation.
• History of selected immune system treatments and/or medications.
• Any medically unstable condition, as assessed by the investigator.
• Selected cardiovascular, or hepatic conditions
• Selected abnormal laboratory values.
• Patients with any other disease or clinical condition (including neurologic or psychiatric disorders) which may affect patient enrollment into the study and study medication use by the Investigators' opinion.
• Participation in any clinical research study evaluating another not approved in Russia investigational drug or therapy within 6 months prior to baseline.
• History of hypersensitivity to the study drug or to drugs of similar chemical classes.
• Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply