This open-label extension study will evaluate the long-term safety of glatiramer acetate and its effect on the neurologic course of participants with relapsing-remitting multiple sclerosis (RRMS). Participants have scheduled visits every 3 months to assess glatiramer acetate safety and their Multiple Sclerosis (MS) status.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms.
Teva Investigational Site 009
Los Angeles, California, United States
Teva Investigational Site 004
Los Angeles, California, United States
Teva Investigational Site 008
New Haven, Connecticut, United States
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Any AEs included both serious and non-serious AEs. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in Reported AE section.
Time frame: Baseline up to Month 288
Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288
The EDSS uses an ordinal scale to assess neurologic impairment in Multiple Sclerosis based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the total EDSS score, ranging from 0 (normal) to 10 (death due to Multiple Sclerosis).
Time frame: Baseline, Month 288
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Teva Investigational Site 005
Baltimore, Maryland, United States
Teva Investigational Site 003
Detroit, Michigan, United States
Teva Investigational Site 002
Albuquerque, New Mexico, United States
Teva Investigational Site 007
Rochester, New York, United States
Teva Investigational Site 001
Philadelphia, Pennsylvania, United States
Teva Investigational Site 010
Houston, Texas, United States
Teva Investigational Site 006
Salt Lake City, Utah, United States
...and 1 more locations