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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01633112
First received: June 29, 2012
Last updated: February 6, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.


Enrollment: 1056
Actual Study Start Date: August 9, 2012
Estimated Study Completion Date: March 23, 2022
Estimated Primary Completion Date: March 23, 2022 (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   (Adult)
Sexes Eligible for Study:   All
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

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Locations
United States, Alabama
Novartis Investigative Site
Cullman, Alabama, United States, 35058
United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85004
Novartis Investigative Site
Phoenix, Arizona, United States, 85013
Novartis Investigative Site
Phoenix, Arizona, United States, 85018
Novartis Investigative Site
Tucson, Arizona, United States, 85741
United States, California
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Los Angeles, California, United States, 90089
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Sacramento, California, United States, 95817
United States, Colorado
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Aurora, Colorado, United States, 80045
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Boulder, Colorado, United States, 80304
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Denver, Colorado, United States, 80220
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Fort Collins, Colorado, United States, 80528
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Loveland, Colorado, United States, 80538
United States, Connecticut
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Fairfield, Connecticut, United States, 06824
United States, Delaware
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Newark, Delaware, United States, 19713
United States, District of Columbia
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Washington, District of Columbia, United States, 20007
United States, Florida
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Jacksonville, Florida, United States, 32209
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Maitland, Florida, United States, 32751
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Naples, Florida, United States, 34119
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New Port Richey, Florida, United States, 34653
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Orlando, Florida, United States, 32806
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Ormond Beach, Florida, United States, 32174
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Pompano Beach, Florida, United States, 33060
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Ponte Vedra Beach, Florida, United States, 32082-4627
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Port Charlotte, Florida, United States, 33952
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Sarasota, Florida, United States, 34243
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Tallahassee, Florida, United States, 32308
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Tampa, Florida, United States, 33609
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Vero Beach, Florida, United States, 32960
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West Palm Beach, Florida, United States, 33407
United States, Georgia
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Atlanta, Georgia, United States, 30327
United States, Illinois
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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
United States, Indiana
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Indianapolis, Indiana, United States, 46202
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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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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
United States, Massachusetts
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Boston, Massachusetts, United States, 02215
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Springfield, Massachusetts, United States, 01104
United States, Michigan
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Detroit, Michigan, United States, 48201
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Detroit, Michigan, United States, 48202
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Grand Rapids, Michigan, United States, 49503
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Novi, Michigan, United States, 48377
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Traverse City, Michigan, United States, 49684-2340
United States, Missouri
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Kansas City, Missouri, United States, 64111
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Saint Louis, Missouri, United States, 63141
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St. Louis, Missouri, United States, 63104
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St. Louis, Missouri, United States, 63131
United States, Montana
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Great Falls, Montana, United States, 59405
United States, Nevada
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Las Vegas, Nevada, United States, 89106
United States, New Jersey
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Freehold, New Jersey, United States, 07728
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Newark, New Jersey, United States, 07103
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Teaneck, New Jersey, United States, 07666
United States, New Mexico
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Albuquerque, New Mexico, United States, 87131
United States, New York
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Albany, New York, United States, 12208
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Amherst, New York, United States, 14226
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Buffalo, New York, United States, 14203
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Patchogue, New York, United States, 11772
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Rochester, New York, United States, 14642
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Stony Brook, New York, United States, 11794
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Syracuse, New York, United States, 13210
United States, North Carolina
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Chapel Hill, North Carolina, United States, 27599-9500
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Charlotte, North Carolina, United States, 28204
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Winston-Salem, North Carolina, United States, 27157
United States, Ohio
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Akron, Ohio, United States, 44320
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Bellevue, Ohio, United States, 44811
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Columbus, Ohio, United States, 43210
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Columbus, Ohio, United States, 43221
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Dayton, Ohio, United States, 45408
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Toledo, Ohio, United States, 43614
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
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Oklahoma City, Oklahoma, United States, 73112
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Tulsa, Oklahoma, United States, 74137
United States, Oregon
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Portloand, Oregon, United States, 97225
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
United States, South Carolina
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Spartanburg, South Carolina, United States, 29302
United States, Tennessee
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Knoxville, Tennessee, United States, 37934
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Memphis, Tennessee, United States, 38128
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Nashville, Tennessee, United States, 37204
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Nashville, Tennessee, United States, 37205
United States, Texas
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Dallas, Texas, United States, 75214
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Houston, Texas, United States, 77030
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Round Rock, Texas, United States, 78681
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San Antonio, Texas, United States, 78258
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Sherman, Texas, United States, 75092
United States, Utah
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Salt Lake City, Utah, United States, 84103
United States, Virginia
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Alexandria, Virginia, United States, 22310
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Charlottesville, Virginia, United States, 22903
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Norfolk, Virginia, United States, 23507
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Richmond, Virginia, United States, 23226
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Roanoke, Virginia, United States, 24018
United States, Washington
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Issaquah, Washington, United States, 98029
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Seattle, Washington, United States, 98101
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Seattle, Washington, United States
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53215
Argentina
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Caba, Buenos Aires, Argentina, C1437JCP
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Buenos aires, Argentina, C1015ABR
Brazil
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Belo Horizonte, Minas Gerais, Brazil, 30150-221
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Porto Alegre, RS, Brazil, 90610-000
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Joinville, SC, Brazil, 89202-451
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Sao Paulo, SP, Brazil, 05651-901
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São Paulo, SP, Brazil, 08270-070
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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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Rio de Janeiro, Brazil, 22610-350
Canada, Alberta
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Edmonton, Alberta, Canada, T6R 2B7
Canada, British Columbia
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Burnaby, British Columbia, Canada, V5G 2X6
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 4K4
Canada, Ontario
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Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H3A 2B4
Chile
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Santiago, Chile, 8380815
Novartis Investigative Site
Santiago, Chile, Piso 1
Mexico
Novartis Investigative Site
Mexico, Distrito Federal, Mexico, 03310
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Tlalnepantla de Baz, Estado de Mexico, Mexico, 54055
Novartis Investigative Site
Monterrey, Nuevo León, Mexico, 64000
Novartis Investigative Site
San Luis Potosi, San Luis Potosí, Mexico, 78240
Novartis Investigative Site
Aguascalientes, Mexico, 20127
Novartis Investigative Site
Chihuahua, Mexico, 31000
Novartis Investigative Site
Chihuahua, Mexico, 31203
Novartis Investigative Site
Monterrey, Mexico, 64460
Puerto Rico
Novartis Investigative Site
Guaynabo, Puerto Rico, 00968
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01633112     History of Changes
Other Study ID Numbers: CFTY720D2312
Study First Received: June 29, 2012
Last Updated: February 6, 2017

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Glatiramer Acetate
Fingolimod Hydrochloride
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on March 24, 2017