Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Fingolimod; Interferon beta - 1a (IFN); Glatiramer acetate (GA)
Intervention description: 0.5 mg orally once a day; 44 mcg subcutaneously three times a week; 20 mg subcutaneously once a day
Intervention MeSH terms: Interferons; Interferon-beta; Glatiramer Acetate; Fingolimod Hydrochloride; (T,G)-A-L
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Relapsing Remitting Multiple Sclerosis (RRMS); Fingolimod; Disease Modifying Therapy (DMT); TSQM-9

Summary:

      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.
    

Eligibility criteria:

        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