A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks
A total of 1000 subjects are planned to be randomized into this study to receive treatment with GA Depot or with matching placebo. During the placebo controlled period (PC period, the first 52 weeks of the study immediately after randomization) subjects will receive either 40mg of GA Depot or matching placebo, IM, once every 4 weeks, for a total of 13 times. Subjects who complete the PC period of the study will be offered to continue into the open label period (OL period) for an additional 52 weeks, in which all subjects will receive 40mg of GA Depot IM once every 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,016
Annualized Relapse Rate (ARR)
Annualized Relapse Rate (ARR) will be derived from the total number of confirmed relapses.
Time frame: 52 weeks
Changes in brain MRI (number of T1 lesions)
Cumulative number of new enhancing lesions on T1-weighted images as compared to baseline.
Time frame: 52 weeks
Changes in brain MRI (number of T2 lesions)
Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline.
Time frame: 52 weeks
Hyperintense T2-lesion volume change
Change from baseline to Week 52 in hyperintense T2-lesion volume.
Time frame: 52 weeks
Enhancing T1-lesion volume change
Change from baseline to Week 52 in enhancing T1-lesion volume.
Time frame: 52 weeks
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