MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone
NCT ID: NCT01633112
Last Updated: 2019-05-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1064 participants
INTERVENTIONAL
2012-08-09
2018-04-30
Brief Summary
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Detailed Description
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This study consisted of 3 periods:
* Screening Period: up to 45 days for all patients
* Treatment Period: 12 months of glatiramer acetate 20 mg, fingolimod 0.25 mg, or fingolimod 0.5 mg
* Follow-up occurred 3 months (12 weeks) after the last dose of study drug for all patients The informed consent form was signed prior to any study related activities at the screening visit. Randomization to either treatment group was preformed at visit 1 after a diligent check of applicable in- and exclusion criteria in a 1:1:1 ratio (changed to 5:3:2 after implementation of Amendment 2 in 2015).
Treatment groups:
* fingolimod 0.5 mg/day orally for up to 12 months
* fingolimod 0.25 mg/day orally for up to 12 months
* glatiramer acetate 20 mg/day subcutaneously for up to 12 months
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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fingolimod 0.5 mg
orally once daily
fingolimod
capsule
fingolimod 0.25mg
orally once daily
fingolimod
capsule
glatiramer acetate 20 mg
subcutaneous once daily
glatiramer acetate
subcutaneous injection
Interventions
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fingolimod
capsule
glatiramer acetate
subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
Exclusion Criteria
* 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 4 weeks before randomization
* Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide, methotrexate) within 6 months before randomization
* Natalizumab within 2 months before randomization
* Previous treatment with lymphocyte-depleting therapies (e.g., rituximab, alemtuzumab, ofatumumab, ocrelizumab, or cladribine) within 1 year before randomization Previous treatment with mitoxantrone within 6 months before randomization
* Use of teriflunomide within 3.5 months prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done. In that case, plasma levels are required to be measured and be below 0.02 mg/L before randomization.
No washout period is necessary for patients treated with dimethyl fumarate, interferon (IFN) beta, or glatiramer acetate.
Patients being treated with dimethyl fumarate, glatiramer acetate, or IFN beta at the Screening visit can continue drug intake up to the day before Day 1 of this study (i.e., there is no need for a washout period).
* Patients who have been treated with systemic corticosteroids or adrenocorticotropic hormones in the past 30 days prior to the screening magnetic resonance imaging (MRI) procedure.
* Patients with uncontrolled diabetes mellitus (glycosylated hemoglobin \>9%) or with diabetic neuropathy.
* 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).
* Patients with severe active bacterial, viral, or fungal infections.
* Patients without acceptable evidence of immunity to varicella zoster virus (VZV) at randomization.
* Patients who have received any live or live-attenuated vaccines (including VZV, 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.
* Patients who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): myocardial infarction, unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure.
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Cullman, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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Aurora, Colorado, United States
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Boulder, Colorado, United States
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Denver, Colorado, United States
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Fort Collins, Colorado, United States
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Loveland, Colorado, United States
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Fairfield, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Naples, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Pompano Beach, Florida, United States
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Ponte Vedra Beach, Florida, United States
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Port Charlotte, Florida, United States
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Sarasota, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Elk Grove Village, Illinois, United States
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Evanston, Illinois, United States
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Flossmoor, Illinois, United States
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Northbrook, Illinois, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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West Des Moines, Iowa, United States
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Kansas City, Kansas, United States
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Lenexa, Kansas, United States
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Louisville, Kentucky, United States
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Hammond, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Detroit, Michigan, United States
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Farmington Hills, Michigan, United States
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Grand Rapids, Michigan, United States
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Traverse City, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Great Falls, Montana, United States
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Las Vegas, Nevada, United States
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Freehold, New Jersey, United States
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Newark, New Jersey, United States
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Teaneck, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Amherst, New York, United States
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Buffalo, New York, United States
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Patchogue, New York, United States
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Rochester, New York, United States
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Stony Brook, New York, United States
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Syracuse, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Bellevue, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Spartanburg, South Carolina, United States
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Cordova, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Sherman, Texas, United States
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Salt Lake City, Utah, United States
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Alexandria, Virginia, United States
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Issaquah, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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CABA, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Belo Horizonte, Minas Gerais, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Joinville, Santa Catarina, Brazil
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São Paulo, São Paulo, Brazil
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Campina Grande do Sul, , Brazil
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Goiânia, , Brazil
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Passo Fundo, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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Burnaby, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Ottawa, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Santiago, , Chile
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Santiago, , Chile
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Tlalnepantla, Edo de Mexico, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Aguascalientes, , Mexico
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Chihuahua City, , Mexico
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Chihuahua City, , Mexico
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Monterrey, , Mexico
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Guaynabo, , Puerto Rico
Countries
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References
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Cree BAC, Goldman MD, Corboy JR, Singer BA, Fox EJ, Arnold DL, Ford C, Weinstock-Guttman B, Bar-Or A, Mientus S, Sienkiewicz D, Zhang Y, Karan R, Tenenbaum N; ASSESS Trial Investigators. Efficacy and Safety of 2 Fingolimod Doses vs Glatiramer Acetate for the Treatment of Patients With Relapsing-Remitting Multiple Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2020 Aug 24;78(1):1-13. doi: 10.1001/jamaneurol.2020.2950. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CFTY720D2312
Identifier Type: -
Identifier Source: org_study_id
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