Multiple Sclerosis - Falls Church VA

Summary:

The purpose of this study is to compare 2 doses (0.25 mg and 0.50 mg) of fingolimod to glatiramer acetate (20 mg) and to evaluate the efficacy of fingolimod 0.25 mg for the treatment of patients with relapsing-remitting MS (RRMS).

A reasonable compensation is paid after the patient completes their participation in the trial. Compensation will be based on number of visits completed.

There will also be an allowed amount of reimbursement for travel and parking expenses when patients submit receipts.

Inclusion criteria:

1. Male and female patients 18 to 65 years of age, inclusive.
2. Patients with RRMS, as defined by 2010 revised McDonald criteria.
3. Patients must be neurologically stable with no onset of relapse or any steroid use within 30 days of randomization
4. Patients with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years before randomization.
5. Patients with an EDSS score of 0 to 6 inclusive at Screening. A score of 6.0 indicates unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting.
6. Patients treated with interferon beta or glatimer acetate can continue their treatment until randomization

1. Patients with a history of malignancy of any organ system (other than cutaneous basal cell carcinoma)
2. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis) or with a known immunodeficiency syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced immune deficiency).
3. Patients who have been treated with:
   • High-dose intravenous (IV) immunoglobulin (Ig) within 2 months before randomization
   • Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide, methotrexate) within 6 months before randomization
   • Monoclonal antibodies (including natalizumab) within 6 months before randomization
   • Rituximab, alemtuzumab, ofatumumab, ocrelizumab, mitoxantrone or cladribine at any time before randomization
4. Patients who have been treated with corticosteroids or adrenocorticotropic hormones in the past 30 days before the screening visit
5. Patients with uncontrolled diabetes mellitus (HbA1c >7%)
6. Patients with a diagnosis of macular edema during Screening (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at Screening)
7. Positive screening for serological markers for hepatitis A, B, C, and E indicating acute or chronic infection:
8. Patients who are negative for varicella zoster virus IgG antibodies at Screening
9. Patients who have received any live or live attenuated vaccines (including for varicella zoster virus, herpes simplex, or measles) within 1 month before randomization
10. Patients who have received total lymphoid irradiation or bone marrow transplantation
11. Patients with any unstable medical/psychiatric condition, as assessed by the primary treating physician at each site