The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS
This was 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 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,064
capsule
subcutaneous injection
Confirmed Annualized Relapse Rate
Annualized relapse rate (ARR) was 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 included all the confirmed relapses experienced during the study from first dose to end of study.
Time frame: up to 12 months
New or Newly Enlarging T2 Lesions
Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.
Time frame: At 12 months/end of study
Number of Participants Free of New/Newly Enlarged T2 Lesions
Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.
Time frame: At 12 months/end of study
Change From Baseline in T2 Lesion Volume
Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion volume
Time frame: Baseline, 12 months/end of study
Gd Enhancing T1 Lesion Count
Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count
Time frame: At 12 months/end of study
Gd Enhancing T1 Lesion Volume
Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count
Time frame: Baseline, 12 months/end of study
Percentage of Patients Free of New T1 Hypointense Lesions
Based on MRI measures of new T1 hypointense lesions
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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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...and 120 more locations
Time frame: 12 months
Change From Baseline in TSQM Scales
Treatment Satisfaction Questionnaire for Medication (TSQM) was developed and validated as a general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug.
Time frame: 6 months, 12 months/end of study
Percent Brain Volume Change From Baseline
Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans were performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.
Time frame: Baseline, 12 months, end of study