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

Use our guide to learn which trials are right for you!

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
Saint Louis, Missouri 63128
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Akron, Ohio 44308
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Alexandria, Virginia 22310
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
Amherst, New York 14226
?
mi
from
Amherst, NY
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80010
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bellevue, Ohio 44811
?
mi
from
Bellevue, OH
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boulder, Colorado 80304
?
mi
from
Boulder, CO
Click here to add this to my saved trials
Buffalo, New York 14215
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Caba, Buenos Aires
?
mi
from
Caba,
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28277
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22904
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Columbus, Ohio 43205
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43205
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Cordova, Tennessee 38018
?
mi
from
Cordova, TN
Click here to add this to my saved trials
Cullman, Alabama 35058
?
mi
from
Cullman, AL
Click here to add this to my saved trials
Dallas, Texas 75216
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dayton, Ohio 45402
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Denver, Colorado 80262
?
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Elk Grove Village, Illinois 60007
?
mi
from
Elk Grove Village, IL
Click here to add this to my saved trials
Evanston, Illinois 60201
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Fairfield, Connecticut 06824
?
mi
from
Fairfield, CT
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
Flossmoor, Illinois 60422
?
mi
from
Flossmoor, IL
Click here to add this to my saved trials
Fort Collins, Colorado 90728
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
Freehold, New Jersey 07728
?
mi
from
Freehold, NJ
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Great Falls, Montana 59405
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
Great Falls, Montana 59405
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
Hammond, Louisiana 70403
?
mi
from
Hammond, LA
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Issaquah, Washington 98029
?
mi
from
Issaquah, WA
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Kansas 66160
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Knoxville, Tennessee 37934
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Las Vegas, Nevada 89135
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lenexa, Kansas 66212
?
mi
from
Lenexa, KS
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Loveland, Colorado 80538
?
mi
from
Loveland, CO
Click here to add this to my saved trials
Maitland, Florida 32751
?
mi
from
Maitland, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53209
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Naples, Florida 34119
?
mi
from
Naples, FL
Click here to add this to my saved trials
Nashville, Tennessee 37205
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37205
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70115
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New Port Richey, Florida 34653
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
Newark, Delaware 19713
?
mi
from
Newark, DE
Click here to add this to my saved trials
Newark, New Jersey 07103
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Northbrook, Illinois 60062
?
mi
from
Northbrook, IL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Patchogue, New York 11772
?
mi
from
Patchogue, NY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pompano Beach, Florida 33060
?
mi
from
Pompano Beach, FL
Click here to add this to my saved trials
Ponte Vedra Beach, Florida 32082
?
mi
from
Ponte Vedra Beach, FL
Click here to add this to my saved trials
Port Charlotte, Florida 33952
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
Portland, OR
Click here to add this to my saved trials
Richmond, Virginia 23249
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Roanoke, Virginia 24014
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
Rochester, New York 14615
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Round Rock, Texas 78681
?
mi
from
Round Rock, TX
Click here to add this to my saved trials
Sacramento, California 95825
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Sacramento, California 95825
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Salt Lake City, Utah 84103
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Sarasota, Florida 34239
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Sarasota, Florida 34239
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Seattle, Washington 98103
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Seattle, Washington 98103
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sherman, Texas 75092
?
mi
from
Sherman, TX
Click here to add this to my saved trials
Spartanburg, South Carolina 29302
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
Springfield, Massachusetts 01104
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Stony Brook, New York 11794
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Teaneck, New Jersey 07666
?
mi
from
Teaneck, NJ
Click here to add this to my saved trials
Toledo, Ohio 43606
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Traverse City, Michigan 49684
?
mi
from
Traverse City, MI
Click here to add this to my saved trials
Tucson, Arizona 85745
?
mi
from
Tucson, AZ
Click here to add this to my saved trials