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



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:10/7/2018
Start Date:August 9, 2012
End Date:April 30, 2018

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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

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).

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

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
We found this trial at
107
sites
Ormond Beach, Florida 32174
2186
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Ormond Beach, FL
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Akron, Ohio 44308
2040
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Akron, OH
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Albany, New York 12208
2438
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Albuquerque, New Mexico 87108
653
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Albuquerque, NM
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Albuquerque, New Mexico 87108
653
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Albuquerque, NM
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Alexandria, Virginia 22310
2277
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Alexandria, VA
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Amherst, New York 14226
2185
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Amherst, NY
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Atlanta, Georgia 30322
1922
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Atlanta, GA
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Aurora, Colorado 80010
824
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Aurora, CO
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Baltimore, Maryland 21287
2302
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Baltimore, MD
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Bellevue, Ohio 44811
1972
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Bellevue, OH
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Boston, Massachusetts 02118
2578
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Boston, MA
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Boulder, Colorado 80304
812
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Boulder, CO
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Buffalo, New York 14215
2184
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Buffalo, NY
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Caba, Buenos Aires
6113
mi
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Caba,
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Chapel Hill, North Carolina 27599
2194
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Charlotte, North Carolina 28277
2104
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Charlotte, NC
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Charlottesville, Virginia 22904
2206
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Charlottesville, VA
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Columbus, Ohio 43205
1962
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Columbus, OH
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Columbus, Ohio 43205
1962
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Columbus, OH
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Cordova, Tennessee 38018
1602
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Cordova, TN
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Cullman, Alabama 35058
1775
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Cullman, AL
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Dallas, Texas 75216
1225
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Dallas, TX
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Dayton, Ohio 45402
1896
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Dayton, OH
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Denver, Colorado 80262
820
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Detroit, Michigan 48202
1965
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Detroit, MI
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Detroit, Michigan 48202
1965
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Detroit, MI
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Elk Grove Village, Illinois 60007
1713
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Elk Grove Village, IL
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Evanston, Illinois 60201
1728
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Evanston, IL
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Fairfield, Connecticut 06824
2468
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Fairfield, CT
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Farmington Hills, Michigan 48334
1952
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Farmington Hills, MI
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Flossmoor, Illinois 60422
1723
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Flossmoor, IL
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Fort Collins, Colorado 90728
839
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Fort Collins, CO
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Freehold, New Jersey 07728
2419
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Freehold, NJ
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Grand Rapids, Michigan 49503
1840
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Grand Rapids, MI
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Great Falls, Montana 59405
990
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Great Falls, MT
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Great Falls, Montana 59405
990
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Hammond, Louisiana 70403
1623
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Hammond, LA
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Houston, Texas 77030
1357
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Houston, TX
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Houston, Texas 77030
1357
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Indianapolis, Indiana 46202
1792
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Indianapolis, Indiana 46202
1792
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Issaquah, Washington 98029
954
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Jacksonville, Florida 32216
2135
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Kansas City, Kansas 66160
1339
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Kansas City, Missouri 64111
1340
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Knoxville, Tennessee 37934
1923
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Las Vegas, Nevada 89135
217
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Lenexa, Kansas 66212
1334
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Los Angeles, California 90095
25
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Louisville, Kentucky 40202
1812
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Loveland, Colorado 80538
833
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Maitland, Florida 32751
2183
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Milwaukee, Wisconsin 53209
1728
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Naples, Florida 34119
2221
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Nashville, Tennessee 37205
1758
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Nashville, Tennessee 37205
1758
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New Orleans, Louisiana 70115
1655
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New Port Richey, Florida 34653
2114
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Newark, Delaware 19713
2345
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Newark, New Jersey 07103
2422
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Norfolk, Virginia 23507
2335
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Northbrook, Illinois 60062
1722
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Oklahoma City, Oklahoma 73104
1165
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Oklahoma City, Oklahoma 73104
1165
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Orlando, Florida 32806
2186
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Patchogue, New York 11772
2484
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Philadelphia, Pennsylvania 19102
2375
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Philadelphia, Pennsylvania 19102
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Philadelphia, Pennsylvania 19102
2375
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Phoenix, Arizona 85012
343
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Phoenix, Arizona 85012
343
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Phoenix, Arizona 85012
343
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Pompano Beach, Florida 33060
2313
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Ponte Vedra Beach, Florida 32082
2147
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Port Charlotte, Florida 33952
2181
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
829
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Portland, OR
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Richmond, Virginia 23249
2267
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Richmond, VA
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Roanoke, Virginia 24014
2136
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Roanoke, VA
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Rochester, New York 14615
2244
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Round Rock, Texas 78681
1208
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Sacramento, California 95825
364
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Sacramento, California 95825
364
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Saint Louis, Missouri 63128
1562
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Salt Lake City, Utah 84103
570
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
1187
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Sarasota, Florida 34239
2148
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Sarasota, FL
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Sarasota, Florida 34239
2148
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Seattle, Washington 98103
965
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Seattle, WA
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Seattle, Washington 98103
965
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Sherman, Texas 75092
1226
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Sherman, TX
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Spartanburg, South Carolina 29302
2043
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Springfield, Massachusetts 01104
2501
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Stony Brook, New York 11794
2478
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Syracuse, New York 13210
2320
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Syracuse, NY
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Tallahassee, Florida 32308
1980
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Tampa, Florida 33613
2133
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Tampa, FL
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Teaneck, New Jersey 07666
2431
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Toledo, Ohio 43606
1933
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Traverse City, Michigan 49684
1864
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Traverse City, MI
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Tucson, Arizona 85745
417
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