A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720
Condition: Multiple Sclerosis; Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fingolimod
Intervention description: Fingolimod 0.5mg orally once a day without food.
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Relapsing remitting multiple sclerosis; Fingolimod; FTY720

Summary:

      The study will assess the patients' satisfaction of treatment after 12 months treatment with
      fingolimod It also will assess the tolerability profile of fingolimod in a small population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with RRMS as described in 2005 Mc Donald criteria

          2. Provided written informed consent prior to any intervention

          3. Female or male patients aged 18-65 years

          4. Unresponsive to treatment with a beta interferon or glatiramer acetate for a minimum
             of one year at and at adequate dose and with high disease activity

             (Unresponsive patients: patients with no changes in relapses, increased relapses,
             severer relapses with one-year treatment or those who had had at least one relapse
             during the past one year under previous treatments and one or multiple contrast
             enhancing lesions in cranial MRI or increased T2 lesions in successive MRIs)

          5. EDSS score below 5.5 at baseline

        Exclusion Criteria:

          -  Treatment-naive RRMS patients 2. History of a chronic disease of the immune system
             other than MS or known immunodeficiency 3. Past or current malignancy 4. Diabetic
             patients with mild or severe, non-proliferative or proliferative diabetic retinopathy
             and uncontrolled diabetic patients with HbA1c > 8% 5. Evidence of macular edema
             (patients with a history of macular edema will be allowed to enter the study provided
             that they do not have macular edema at screening.) 6. Evidence of uveitis 7. EDSS
             score > 5.5 at baseline 8. Active systemic bacterial, viral or fungal infections, or
             known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody,
             Hepatitis B surface antigen or Hepatitis C antibody tests 9. No history of varicella
             and negative varicella-zoster virus IhH antibody test at screening (such patients may
             be included after being administered VZV vaccine, at least 1 month following
             vaccination.) 10. Patients who received any live or live attenuated vaccine during the
             last one month (including varicella-zoster virus or measles) 11. Patients who received
             total lymphoid irradiation or bone marrow transplantation 12. Patient who received any
             of the treatment below:

               1. Corticosteroids or adrenocorticotropic hormone (ACTH) during the last 1 month

               2. Immunosuppressive medications such as azathioprine or methotrexate etc.

               3. Immunoglobulin treatment during the last 3 months

               4. Cladribine, cyclophosphamide, mitoxantrone, natalizumab at any time 13. Patients
                  with any of the following cardiovascular conditions: Resting heart rate < 45
                  bpm/min Cardiac failure at time of screening (Class III according to NYHA
                  classification) or any severe cardiac as determined by the physician Myocardial
                  infarction during the last 6 months History of Mobitz Type II grade 2 AV block
                  Past or current grade 3 AV block Confirmed history of sick sinus syndrome or
                  sino-atrial heart block arrhythmia requiring current treatment with Class Ia
                  drugs (ajmaline, disopyramid, procainamide, quinidine) hypertension uncontrolled
                  with medication 14. Patients with any of the pulmonary conditions below severe
                  respiratory disease or pulmonary fibrosis Uncontrolled asthma 15. Pregnant or
                  nursing (lactating) women (pregnancy is defined as the state of a female after
                  conception and until the termination of gestation and should be confirmed by a
                  positive hCG laboratory test (> 5 mIU/ml).

                  16. Patients with any of the hepatic conditions below: Alcohol abuse, chronic
                  hepatic or biliary disease, severe hepatic impairment (Child- Pugh class C) Total
                  bilirubin above the upper limit of normal provided that it is not associated with
                  Gilbert's syndrome Conjugated bilirubin above the upper limit of normal Alkaline
                  phosphate (AP) 1.5 times above the upper limit of normal AST(SGOT), ALT (SGPT) 2
                  times above the upper limit of normal, gamma-glutamyl-transferase (GGT) 3 times
                  above the upper limit of normal