This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
255
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.
Time frame: Baseline , Week 12, 24, 28, 32, 36, 40
Mean Annualized Relapse Rate (ARR)
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).
Time frame: Baseline up to Week 40
Percentage of Subjects Remaining Relapse-Free
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0.
Time frame: Baseline up to Week 40
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
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Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
Research site
Redding, California, United States
Research site
San Diego, California, United States
Research site
San Diego, California, United States
Research site
Fairfield, Connecticut, United States
Research site
Dover, Delaware, United States
Research site
Miami, Florida, United States
Research site
Naples, Florida, United States
Research site
Pompano Beach, Florida, United States
Research site
Sarasota, Florida, United States
Research site
Sunrise, Florida, United States
...and 108 more locations
T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.
Time frame: Weeks 12, 24, 28, 32, 36, 40
Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan
New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans.
Time frame: Weeks 12, 24, 28, 32, 36,40
Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan
New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.
Time frame: Weeks 12, 24, 28, 32, 36, 40
Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans.
Time frame: Baseline, Weeks 12, 24, 28, 32, 36, 40
Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan.
Time frame: Baseline, Weeks 12, 24, 28, 32, 36, 40
Time to First Relapse
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0.
Time frame: Baseline up to Week 40
Mean Change From Baseline in Brain Volume Per Subject
Change from baseline in brain volume per subject was calculated using 5 series MRI scan.
Time frame: Baseline, Weeks 24, 28, 32, 36, 40