MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01633112
First received: June 29, 2012
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis (RRMS)
Drug: fingolimod
Drug: copaxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Comparison of 2 doses (0.25 mg and .5 mg) of fingolimod to glatiramer acetate (20 mg) in reducing the annualized relapse rate up to 12 months [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    The annualized relapse rate (ARR) which is defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses will include all the confirmed relapses experienced during the study from first dose to end of study.


Secondary Outcome Measures:
  • change from Baseline in brain volume [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • number of active T2 lesions (new or newly enlarging lesions compared with Baseline) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • proportion of patients free of new or newly enlarging T2 lesions compared to Baseline [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • change from Baseline in T2 lesion volume [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • change from Baseline in the number and volume of T1 hypointense lesions [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • number and volume of gadolinium (Gd)-enhancing T1 lesions [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • safety and tolerability [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.

  • change from baseline in treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans will be performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.


Estimated Enrollment: 2550
Study Start Date: August 2012
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fingolimod 0.5 mg orally once daily Drug: fingolimod
Other Name: FTY720
Experimental: fingolimod 0.25mg orally once daily Drug: fingolimod
Other Name: FTY720
Active Comparator: copaxone 20 mg s.c. once daily Drug: copaxone
copaxone

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633112

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, Alabama
Novartis Investigative Site Recruiting
Cullman, Alabama, United States, 35058
Novartis Investigative Site Withdrawn
Huntsville, Alabama, United States, 35801
United States, Arizona
Novartis Investigative Site Withdrawn
Gilbert, Arizona, United States, 85234
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85004
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85018
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85013
Novartis Investigative Site Withdrawn
Sun City, Arizona, United States, 85351
Novartis Investigative Site Terminated
Tucson, Arizona, United States, 85741
United States, Arkansas
Novartis Investigative Site Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
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Berkeley, California, United States, 94705
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Fresno, California, United States, 93710
Novartis Investigative Site Withdrawn
La Jolla, California, United States, 92037
Novartis Investigative Site Withdrawn
Los Alamitos, California, United States, 90720
Novartis Investigative Site Recruiting
Los Angeles, California, United States, 90089-2821
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Oceanside, California, United States, 92056
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Sacramento, California, United States, 95817
Novartis Investigative Site Withdrawn
Sacramento, California, United States, 95816-5199
Novartis Investigative Site Withdrawn
San Francisco, California, United States, 94117
Novartis Investigative Site Recruiting
Torrance, California, United States, 90509
United States, Colorado
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Aurora, Colorado, United States, 80045
Novartis Investigative Site Withdrawn
Boulder, Colorado, United States, 80304
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Colorado Springs, Colorado, United States, 80920
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Denver, Colorado, United States, 80220
Novartis Investigative Site Withdrawn
Denver, Colorado, United States, 80218
Novartis Investigative Site Withdrawn
Englewood, Colorado, United States, 80113
Novartis Investigative Site Completed
Fort Collins, Colorado, United States, 80528
Novartis Investigative Site Recruiting
Fort Collins, Colorado, United States, 80525
United States, Connecticut
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Derby, Connecticut, United States, 06418
Novartis Investigative Site Recruiting
Fairfield, Connecticut, United States, 06824
United States, Delaware
Novartis Investigative Site Recruiting
Newark, Delaware, United States, 19713
United States, District of Columbia
Novartis Investigative Site Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Novartis Investigative Site Not yet recruiting
Delray Beach, Florida, United States, 33445
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Hollywood, Florida, United States, 33021
Novartis Investigative Site Recruiting
Jacksonville, Florida, United States, 32209
Novartis Investigative Site Recruiting
Maitland, Florida, United States, 32751
Novartis Investigative Site Withdrawn
Miami, Florida, United States, 33136
Novartis Investigative Site Terminated
Naples, Florida, United States, 34119
Novartis Investigative Site Terminated
New Port Richey, Florida, United States, 34653
Novartis Investigative Site Terminated
Orlando, Florida, United States, 32806
Novartis Investigative Site Recruiting
Ormond Beach, Florida, United States, 32174
Novartis Investigative Site Withdrawn
Plantation, Florida, United States, 33324
Novartis Investigative Site Recruiting
Pompano Beach, Florida, United States, 33060
Novartis Investigative Site Recruiting
Ponte Vedra Beach, Florida, United States, 32082-4627
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Port Charlotte, Florida, United States, 33952
Novartis Investigative Site Not yet recruiting
Sarasota, Florida, United States, 34233
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Sarasota, Florida, United States, 34243
Novartis Investigative Site Withdrawn
St. Petersburg, Florida, United States, 33713
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Tallahassee, Florida, United States, 32308
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Tampa, Florida, United States, 33612
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Tampa, Florida, United States, 33609
Novartis Investigative Site Recruiting
Vero Beach, Florida, United States, 32960
Novartis Investigative Site Recruiting
West Palm Beach, Florida, United States, 33407
United States, Georgia
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Atlanta, Georgia, United States, 30327
Novartis Investigative Site Not yet recruiting
Douglasville, Georgia, United States, 30134
United States, Illinois
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Chicago, Illinois, United States, 60612
Novartis Investigative Site Suspended
Elk Grove Village, Illinois, United States, 60007
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Elk Grove Village, Illinois, United States, 60007
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Evanston, Illinois, United States, 60201
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Flossmoor, Illinois, United States, 60422
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Northbrook, Illinois, United States, 60062
Novartis Investigative Site Withdrawn
Palos Heights, Illinois, United States, 60463
United States, Indiana
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Indianapolis, Indiana, United States, 46202
Novartis Investigative Site Completed
Indianapolis, Indiana, United States, 46256
United States, Iowa
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West Des Moines, Iowa, United States, 50314
United States, Kansas
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Kansas City, Kansas, United States, 66160
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Lenexa, Kansas, United States, 66212
United States, Kentucky
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Lexington, Kentucky, United States, 40536
Novartis Investigative Site Recruiting
Louisville, Kentucky, United States, 40207
United States, Louisiana
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Hammond, Louisiana, United States, 70403
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New Orleans, Louisiana, United States, 70121
United States, Maryland
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Baltimore, Maryland, United States, 21201
Novartis Investigative Site Withdrawn
Baltimore, Maryland, United States, 21287-6985
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02115
Novartis Investigative Site Withdrawn
Brookline, Massachusetts, United States, 02445
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Quincy, Massachusetts, United States, 02169
Novartis Investigative Site Recruiting
Springfield, Massachusetts, United States, 01104
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Worchester, Massachusetts, United States, 01655
United States, Michigan
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Clinton Township, Michigan, United States, 48035
Novartis Investigative Site Recruiting
Detroit, Michigan, United States, 48201
Novartis Investigative Site Completed
Detroit, Michigan, United States, 48202
Novartis Investigative Site Recruiting
Grand Rapids, Michigan, United States, 49503
Novartis Investigative Site Recruiting
Novi, Michigan, United States, 48377
Novartis Investigative Site Completed
Traverse City, Michigan, United States, 49684-2340
United States, Minnesota
Novartis Investigative Site Withdrawn
Golden Valley, Minnesota, United States, 55422
United States, Mississippi
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Ocean Springs, Mississippi, United States, 39564
United States, Missouri
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Kansas City, Missouri, United States, 64111
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Saint Louis, Missouri, United States, 63141
Novartis Investigative Site Terminated
St. Louis, Missouri, United States, 63104
Novartis Investigative Site Recruiting
St. Louis, Missouri, United States, 63131
United States, Montana
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Great Falls, Montana, United States, 59405
Novartis Investigative Site Recruiting
Great Falls, Montana, United States, 59405
United States, Nebraska
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Omaha, Nebraska, United States, 68198-2045
United States, Nevada
Novartis Investigative Site Recruiting
Las Vegas, Nevada, United States, 89106
United States, New Jersey
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Freehold, New Jersey, United States, 07728
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New Brunswick, New Jersey, United States, 08901
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Newark, New Jersey, United States, 07103
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Stratford, New Jersey, United States, 08084
Novartis Investigative Site Recruiting
Teaneck, New Jersey, United States, 7666
United States, New Mexico
Novartis Investigative Site Recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Novartis Investigative Site Completed
Albany, New York, United States, 12208
Novartis Investigative Site Withdrawn
Albany, New York, United States, 12208
Novartis Investigative Site Withdrawn
Albany, New York, United States, 12205
Novartis Investigative Site Recruiting
Amherst, New York, United States, 14226
Novartis Investigative Site Recruiting
Buffalo, New York, United States, 14203
Novartis Investigative Site Withdrawn
New York, New York, United States, 10029
Novartis Investigative Site Recruiting
Patchogue, New York, United States, 11772
Novartis Investigative Site Withdrawn
Plainview, New York, United States, 11803
Novartis Investigative Site Recruiting
Rochester, New York, United States, 14642
Novartis Investigative Site Recruiting
Stony Brook, New York, United States, 11794
Novartis Investigative Site Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Novartis Investigative Site Withdrawn
Advance, North Carolina, United States, 27006
Novartis Investigative Site Withdrawn
Asheville, North Carolina, United States, 28806
Novartis Investigative Site Recruiting
Chapel Hill, North Carolina, United States, 27599-9500
Novartis Investigative Site Recruiting
Charlotte, North Carolina, United States, 28204
Novartis Investigative Site Withdrawn
Charlotte, North Carolina, United States, 28207
Novartis Investigative Site Withdrawn
Salisbury, North Carolina, United States, 28144
Novartis Investigative Site Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Novartis Investigative Site Recruiting
Akron, Ohio, United States, 44320
Novartis Investigative Site Recruiting
Bellevue, Ohio, United States, 44811
Novartis Investigative Site Withdrawn
Canton, Ohio, United States, 44718
Novartis Investigative Site Withdrawn
Cincinnati, Ohio, United States, 45219
Novartis Investigative Site Withdrawn
Cleveland, Ohio, United States, 44195
Novartis Investigative Site Recruiting
Columbus, Ohio, United States, 43221
Novartis Investigative Site Recruiting
Columbus, Ohio, United States, 43210
Novartis Investigative Site Recruiting
Dayton, Ohio, United States, 45408
Novartis Investigative Site Not yet recruiting
Dayton, Ohio, United States, 45408
Novartis Investigative Site Recruiting
Toledo, Ohio, United States, 43614
Novartis Investigative Site Withdrawn
Uniontown, Ohio, United States, 44685
United States, Oklahoma
Novartis Investigative Site Recruiting
Oklahoma City, Oklahoma, United States, 73104
Novartis Investigative Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
Novartis Investigative Site Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Novartis Investigative Site Recruiting
Tulsa, Oklahoma, United States, 74137
United States, Oregon
Novartis Investigative Site Recruiting
Portloand, Oregon, United States, 97225
United States, Pennsylvania
Novartis Investigative Site Withdrawn
Altoona, Pennsylvania, United States, 16602
Novartis Investigative Site Withdrawn
Greensburg, Pennsylvania, United States, 15601
Novartis Investigative Site Withdrawn
Hershey, Pennsylvania, United States, 17033
Novartis Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
Novartis Investigative Site Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Novartis Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19141
Novartis Investigative Site Withdrawn
Philadelphia, Pennsylvania, United States, 19107
Novartis Investigative Site Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Novartis Investigative Site Withdrawn
Providence, Rhode Island, United States, 02905
United States, South Carolina
Novartis Investigative Site Withdrawn
Port Royal, South Carolina, United States, 29935
Novartis Investigative Site Recruiting
Spartanburg, South Carolina, United States, 29302
United States, Tennessee
Novartis Investigative Site Recruiting
Cordova, Tennessee, United States, 38018
Novartis Investigative Site Recruiting
Knoxville, Tennessee, United States, 37934
Novartis Investigative Site Recruiting
Nashville, Tennessee, United States, 37205
Novartis Investigative Site Recruiting
Nashville, Tennessee, United States, 37204
United States, Texas
Novartis Investigative Site Withdrawn
Dallas, Texas, United States, 75246
Novartis Investigative Site Withdrawn
Dallas, Texas, United States, 75390-9063
Novartis Investigative Site Withdrawn
Dallas, Texas, United States, 75390
Novartis Investigative Site Recruiting
Dallas, Texas, United States, 75214
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77030
Novartis Investigative Site Withdrawn
Houston, Texas, United States, 77076
Novartis Investigative Site Recruiting
Round Rock, Texas, United States, 78681
Novartis Investigative Site Recruiting
San Antonio, Texas, United States, 78258
Novartis Investigative Site Withdrawn
San Antonio, Texas, United States, 78231
Novartis Investigative Site Withdrawn
San Antonio, Texas, United States, 78229
Novartis Investigative Site Recruiting
Sherman, Texas, United States, 75092
United States, Utah
Novartis Investigative Site Completed
Salt Lake City, Utah, United States, 84103
United States, Virginia
Novartis Investigative Site Recruiting
Alexandria, Virginia, United States, 22310
Novartis Investigative Site Withdrawn
Alexandria, Virginia, United States, 22304
Novartis Investigative Site Recruiting
Charlottesville, Virginia, United States, 22903
Novartis Investigative Site Recruiting
Henrico, Virginia, United States, 23226
Novartis Investigative Site Not yet recruiting
Norfolk, Virginia, United States, 23507
Novartis Investigative Site Recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Novartis Investigative Site Recruiting
Issaquah, Washington, United States, 98029
Novartis Investigative Site Recruiting
Seattle, Washington, United States, 98101
Novartis Investigative Site Terminated
Seattle, Washington, United States
United States, Wisconsin
Novartis Investigative Site Not yet recruiting
Milwaukee, Wisconsin, United States, 53215
Argentina
Novartis Investigative Site Withdrawn
Caba, Buenos Aires, Argentina, C1280AEB
Novartis Investigative Site Recruiting
Buenos Aires, Argentina, C1437JCP
Novartis Investigative Site Recruiting
Buenos aires, Argentina, C1015ABR
Novartis Investigative Site Not yet recruiting
Cordoba, Argentina, X5004CDT
Novartis Investigative Site Withdrawn
Cordoba, Argentina, X5000FAL
Novartis Investigative Site Withdrawn
Martínez, Argentina, B1640HEC
Brazil
Novartis Investigative Site Not yet recruiting
Porto Alegre, RS, Brazil, 90610-000
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Joinville, SC, Brazil, 89202-165
Novartis Investigative Site Not yet recruiting
São Paulo, SP, Brazil, 08270-070
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São Paulo, SP, Brazil, 05651-901
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Belo Horizonte, Brazil, 30110-090
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Campina Grande do Sul, Brazil, 83430-000
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Goiânia, Brazil, 74605-020
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Passo Fundo, Brazil, 99010-080
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Porto Alegre, Brazil, 90020-090
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Rio de Janeiro, Brazil, 22610-350
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Rio Grande do Sul, Brazil, 90035-001
Canada, Alberta
Novartis Investigative Site Withdrawn
Calgary, Alberta, Canada, T2N 2T9
Novartis Investigative Site Recruiting
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Novartis Investigative Site Recruiting
Burnaby, British Columbia, Canada, V5G 2X6
Canada, Nova Scotia
Novartis Investigative Site Recruiting
Halifax, Nova Scotia, Canada, B3H 4K4
Canada, Ontario
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Kingston, Ontario, Canada, K7L 2V7
Novartis Investigative Site Recruiting
Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M5B-1W8
Canada, Quebec
Novartis Investigative Site Recruiting
Chicoutimi, Quebec, Canada, G7H 5H6
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Gatineau, Quebec, Canada, J9J 0A5
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Montreal, Quebec, Canada, H3A 2B4
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H1T 2M4
Canada
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Quebec, Canada, J4V 2J2
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Regina, Canada, S4T 1A5
Chile
Novartis Investigative Site Recruiting
Santiago, Chile, Piso 1
Novartis Investigative Site Recruiting
Santiago, Chile, 8380815
Novartis Investigative Site Withdrawn
Santiago, Chile
Mexico
Novartis Investigative Site Not yet recruiting
Guadalajara, Jalisco, Mexico, 44280
Novartis Investigative Site Withdrawn
Guadaljara, Jalisco, Mexico, 44620
Novartis Investigative Site Recruiting
Monterrey, Nuevo León, Mexico, 64000
Novartis Investigative Site Recruiting
San Luis Potosi, San Luis Potosí, Mexico, 78240
Novartis Investigative Site Recruiting
Aguascalientes, Mexico, 20127
Novartis Investigative Site Recruiting
Chihuahua, Mexico, 31000
Novartis Investigative Site Recruiting
Chihuahua, Mexico, 31203
Novartis Investigative Site Withdrawn
Culiacan, Mexico, 80020
Novartis Investigative Site Not yet recruiting
Mexico City, Mexico, 5300
Novartis Investigative Site Recruiting
Mexico City, Mexico, 3310
Novartis Investigative Site Recruiting
Monterrey, Mexico, 64460
Novartis Investigative Site Withdrawn
Morelia, Mexico, 5800
Novartis Investigative Site Not yet recruiting
Tlalnepantla, Mexico, 54055
Puerto Rico
Novartis Investigative Site Recruiting
Guaynabo, Puerto Rico, 00969
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01633112     History of Changes
Other Study ID Numbers: CFTY720D2312
Study First Received: June 29, 2012
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Copolymer 1
Fingolimod
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014