* This is a phase IIa study in which GA Depot 80 or 40mg is administered as an IM injection to subjects with RRMS at 4 week intervals for 52 weeks of treatment. * The purpose of the study is to assess safety, tolerability, and efficacy of a monthly long-acting IM injection of 80 or 40mg GA Depot in subjects with RRMS. The study will include subjects switching from daily or thrice weekly administration of 20 mg or 40mg respectively of glatiramer acetate (GA, i.e., Copaxone®) injection
* 25 Subjects with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who are treated with daily or thrice weekly subcutaneous injections of 20 mg or 40 mg respectively of GA (Copaxone®) during the previous 12 months * Study product is GA long-acting injection (GA Depot) which is a combination of extended-release microspheres for injection and diluent (water for injection) for parenteral use. GA Depot will be administered intramuscularly (IM). * The study duration for an individual subject in the core study will be 60 weeks, consisting of 4 weeks of screening evaluation (weeks -4 to 0), followed by a 52-week open-label treatment period, and a 4 weeks follow up period: through a total of 17 visits. * For both arms, subjects who completed 13 injections and who consented (by signing an informed consent) are able to enter the optional 8 years extension period. During the extension period subjects will receive 40 mg of GA Depot IM once every 4 weeks. * Physical, vital signs and safety assessment - will be performed at each visit during the whole study. Physical examination will be performed quarterly during the extension period. * MRI at visit 1 (screenings), at week 24, week 52 (end of core study) and every 6 months during the extension period. * Neurological and safety laboratory tests at screening visit, on visits in weeks 4, 12, 24, 36, 52 (end of core study) and every 6 months during the extension period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
Recruitment completed
Recruitment completed
Barzilai Medical Center
Ashkelon, Israel
Rambam Medical Center
Haifa, Israel
TASMC
Tel Aviv, Israel
Safety / Adverse events
Number of patients experiencing adverse events and assessments of localized skin reactions at injection sites.
Time frame: During the study (1 year treatment)
Efficacy/Change in Relapse Rate
Relapse rate detected during the study compared to relapse rate observed in the 12 months prior to study start.
Time frame: During the study (1 year treatment)
Efficacy/Changes in brain MRI
Changes from baseline to end of treatment visit in the number of enhancing lesions and new lesions images of brain MRI
Time frame: During the study (1 year treatment)
Efficacy/Changes in EDSS
Change from baseline to end of treatment visit of Expanded Disability Status Scale (EDSS) score.
Time frame: 1 year
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