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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 Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis

Description

Brief 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).


Detailed Description
This is a multicenter, randomized, rater- and dose-blinded, study to compare the efficacy and safety of 0.25 mg and 0.5 mg of fingolimod with glatimer acetate 20 mg s.c. in patients with RRMS. This study will consist of 3 periods: - Screening Period: up to 1 month for all patients - Treatment Period: 12 months of glatiramer acetate 20 mg, fingolimod 0.25 mg, or fingolimod 0.5 mg - Follow-up will occur 3 months (12 weeks) after the last dose of study drug for all patients After signing the informed consent, patients will enter the Screening Period to determine eligibility for the study. After inclusion/exclusion criteria are reviewed again and after safety assessments are conducted, patients will enter the Treatment Period and will be randomly assigned into 1 of 3 groups in a 1:1:1 ratio: - Group 1 will receive fingolimod 0.5 mg orally once a day for up to 12 months - Group 2 will receive fingolimod 0.25 mg orally once a day for up to 12 months - Group 3 will receive glatiramer acetate 20 mg subcutaneously once a day for up to 12 months

Phase

Phase 3/4

Inclusion and Exclusion 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

  • 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

Sites

  • California

    • Novartis Investigative Site, Torrance, California, 90509
    • Novartis Investigative Site, Los Alamitos, California, 90720
    • Novartis Investigative Site, Oceanside, California, 92056
    • Novartis Investigative Site, La Jolla, California, 92037
    • Novartis Investigative Site, Fresno, California, 93710
    • Novartis Investigative Site, Berkeley, California, 94705
    • Novartis Investigative Site, San Francisco, California, 94117
    • Novartis Investigative Site, Sacramento, California, 95817
  • Nevada

    • Novartis Investigative Site, Las Vegas, Nevada, 89106
  • Arizona

    • Novartis Investigative Site, Sun City, Arizona, 85351
    • Novartis Investigative Site, Phoenix, Arizona, 85013
    • Novartis Investigative Site, Phoenix, Arizona, 85004
    • Novartis Investigative Site, Phoenix, Arizona, 85018
    • Novartis Investigative Site, Gilbert, Arizona, 85234
    • Novartis Investigative Site, Tucson, Arizona, 85741
  • Utah

    • Novartis Investigative Site, Salt Lake City, Utah, 84103
  • New Mexico

    • Novartis Investigative Site, Albuquerque, New Mexico, 87131
  • Colorado

    • Novartis Investigative Site, Colorado Springs, Colorado, 80920
    • Novartis Investigative Site, Boulder, Colorado, 80304
    • Novartis Investigative Site, Denver, Colorado, 80218
    • Novartis Investigative Site, Denver, Colorado, 80220
    • Novartis Investigative Site, Aurora, Colorado, 80045
    • Novartis Investigative Site, Fort Collins, Colorado, 80525
    • Novartis Investigative Site, Fort Collins, Colorado, 80528
  • Oregon

    • Novartis Investigative Site, Portloand, Oregon, 97225
  • Washington

    • Novartis Investigative Site, Issaquah, Washington, 98029
    • Novartis Investigative Site, Seattle, Washington, 98101
  • Montana

    • Novartis Investigative Site, Great Falls, Montana, 59405
    • Novartis Investigative Site, Great Falls, Montana, 59405
  • Oklahoma

    • Novartis Investigative Site, Oklahoma City, Oklahoma, 73112
    • Novartis Investigative Site, Oklahoma City, Oklahoma, 73104
    • Novartis Investigative Site, Oklahoma City, Oklahoma, 73104
    • Novartis Investigative Site, Tulsa, Oklahoma, 74137
  • Texas

    • Novartis Investigative Site, San Antonio, Texas, 78229
    • Novartis Investigative Site, San Antonio, Texas, 78231
    • Novartis Investigative Site, San Antonio, Texas, 78258
    • Novartis Investigative Site, Round Rock, Texas, 78681
    • Novartis Investigative Site, Sherman, Texas, 75092
    • Novartis Investigative Site, Dallas, Texas, 75246
    • Novartis Investigative Site, Dallas, Texas, 75390
    • Novartis Investigative Site, Dallas, Texas, 75214
    • Novartis Investigative Site, Houston, Texas, 77076
    • Novartis Investigative Site, Houston, Texas, 77030
  • Kansas

    • Novartis Investigative Site, Kansas City, Kansas, 66160
    • Novartis Investigative Site, Lenexa, Kansas, 66212
  • Missouri

    • Novartis Investigative Site, Kansas City, Missouri, 64111
    • Novartis Investigative Site, Saint Louis, Missouri, 63141
    • Novartis Investigative Site, St. Louis, Missouri, 63131
    • Novartis Investigative Site, St. Louis, Missouri, 63104
  • Iowa

    • Novartis Investigative Site, West Des Moines, Iowa, 50314
  • Arkansas

    • Novartis Investigative Site, Little Rock, Arkansas, 72205
  • Minnesota

    • Novartis Investigative Site, Golden Valley, Minnesota, 55422
  • Tennessee

    • Novartis Investigative Site, Cordova, Tennessee, 38018
    • Novartis Investigative Site, Nashville, Tennessee, 37205
    • Novartis Investigative Site, Nashville, Tennessee, 37204
  • Louisiana

    • Novartis Investigative Site, Hammond, Louisiana, 70403
    • Novartis Investigative Site, New Orleans, Louisiana, 70121
  • Illinois

    • Novartis Investigative Site, Elk Grove Village, Illinois, 60007
    • Novartis Investigative Site, Elk Grove Village, Illinois, 60007
    • Novartis Investigative Site, Palos Heights, Illinois, 60463
    • Novartis Investigative Site, Northbrook, Illinois, 60062
    • Novartis Investigative Site, Flossmoor, Illinois, 60422
    • Novartis Investigative Site, Chicago, Illinois, 60612
    • Novartis Investigative Site, Evanston, Illinois, 60201
  • Mississippi

    • Novartis Investigative Site, Ocean Springs, Mississippi, 39564
  • Wisconsin

    • Novartis Investigative Site, Milwaukee, Wisconsin, 53215
  • Alabama

    • Novartis Investigative Site, Cullman, Alabama, 35058
    • Novartis Investigative Site, Huntsville, Alabama, 35801
  • Indiana

    • Novartis Investigative Site, Indianapolis, Indiana, 46202
    • Novartis Investigative Site, Indianapolis, Indiana, 46256
  • Kentucky

    • Novartis Investigative Site, Louisville, Kentucky, 40207
    • Novartis Investigative Site, Lexington, Kentucky, 40536
  • Michigan

    • Novartis Investigative Site, Grand Rapids, Michigan, 49503
  • Ohio

    • Novartis Investigative Site, Cincinnati, Ohio, 45219
    • Novartis Investigative Site, Dayton, Ohio, 45408
    • Novartis Investigative Site, Dayton, Ohio, 45408
  • Georgia

    • Novartis Investigative Site, Douglasville, Georgia, 30134
    • Novartis Investigative Site, Douglasville, Georgia, 30134
    • Novartis Investigative Site, Atlanta, Georgia, 30327
  • Mexico

    • Novartis Investigative Site, Culiacan, 80020
  • San Luis Potosí

    • Novartis Investigative Site, San Luis Potosi, San Luis Potosí, 78240
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