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A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subc

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Trial Conditions
  • Relapsing-remitting Multiple Sclerosis (RRMS)
What is the purpose of this trial?

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).

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18  - 55 

Gender:
Both

Eligibility

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 or any steroid use
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.

- Patients treated with interferon beta or glatimer acetate can continue their
treatment until randomization

Exclusion criteria:

- Patients with a history of malignancy of any organ system (other than cutaneous basal
cell carcinoma)

- 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 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

- Patients who have been treated with corticosteroids or adrenocorticotropic hormones
in the past 30 days before the screening visit

- Patients with uncontrolled diabetes mellitus (HbA1c >7%)

- 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)

- Positive screening for serological markers for hepatitis A, B, C, and E indicating
acute or chronic infection:

- Patients who are negative for varicella zoster virus IgG antibodies at Screening

- Patients who have received any live or live attenuated vaccines (including for
varicella zoster virus, 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

Gender: Both
Steward Physician(s)
  • Novartis Pharmaceuticals
Trial Interventions
Drug
  • fingolimod
  • copaxone
Physician Researcher

Investigator Name:

  • Novartis Pharmaceuticals

Other Information

Sponsor: Novartis Pharmaceuticals
Phase: Phase 4
Trial ID: NCT01633112
Volunteers:  Not Accepting Healthy Volunteers

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