MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone
Condition: Relapsing-remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: fingolimod; glatiramer acetate
Intervention description: capsule; subcutaneous injection
Intervention MeSH terms: Glatiramer Acetate; Fingolimod Hydrochloride; (T,G)-A-L
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Fingolimod patients were dose blind.
Enrollment: 1064.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25
      mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12
      months in patients with relapsing-remitting MS
    

Eligibility criteria:

        Inclusion criteria:

          -  Written informed consent must be obtained before any assessment is performed

          -  Male and female patients 18 to 65 years of age, inclusive.

          -  Patients with RRMS, as defined by 2010 revised McDonald criteria.

          -  Patients must be neurologically stable with no onset of relapse within 30 days of
             randomization

          -  Patients with at least 1 documented relapse during the previous year or 2 documented
             relapses during the previous 2 years before randomization.

          -  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.

        Exclusion criteria:

          -  Patients with a history of malignancy of any organ system (other than cutaneous basal
             cell carcinoma) in the last 5 years that do not have confirmation of absence of a
             malignancy prior to randomization

          -  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).

          -  Patients who have been treated with:

          -  High-dose intravenous (IV) immunoglobulin (Ig) within 4 weeks before randomization

          -  Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide,
             methotrexate) within 6 months before randomization

          -  Natalizumab within 2 months before randomization

          -  Previous treatment with lymphocyte-depleting therapies (e.g., rituximab, alemtuzumab,
             ofatumumab, ocrelizumab, or cladribine) within 1 year before randomization Previous
             treatment with mitoxantrone within 6 months before randomization

          -  Use of teriflunomide within 3.5 months prior to randomization, except if active
             washout (with either cholestyramine or activated charcoal) was done. In that case,
             plasma levels are required to be measured and be below 0.02 mg/L before randomization.

        No washout period is necessary for patients treated with dimethyl fumarate, interferon
        (IFN) beta, or glatiramer acetate.

        Patients being treated with dimethyl fumarate, glatiramer acetate, or IFN beta at the
        Screening visit can continue drug intake up to the day before Day 1 of this study (i.e.,
        there is no need for a washout period).

          -  Patients who have been treated with systemic corticosteroids or adrenocorticotropic
             hormones in the past 30 days prior to the screening magnetic resonance imaging (MRI)
             procedure.

          -  Patients with uncontrolled diabetes mellitus (glycosylated hemoglobin >9%) or with
             diabetic neuropathy.

          -  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).

          -  Patients with severe active bacterial, viral, or fungal infections.

          -  Patients without acceptable evidence of immunity to varicella zoster virus (VZV) at
             randomization.

          -  Patients who have received any live or live-attenuated vaccines (including VZV, herpes
             simplex, or measles) within 1 month before randomization.

          -  Patients who have received total lymphoid irradiation or bone marrow transplantation.

          -  Patients with any unstable medical/psychiatric condition, as assessed by the primary
             treating physician at each site.

          -  Patients who in the last 6 months experienced any of the following cardiovascular
             conditions or findings in the screening electrocardiogram (ECG): myocardial
             infarction, unstable angina, stroke, transient ischemic attack or decompensated heart
             failure requiring hospitalization or Class III/IV heart failure.