Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Relapsing Remitting, Plovamer acetate, Copaxone
Brief summary
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.
Interventions
DRUGPlovamer acetate 0.5 milligram (mg)
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.
DRUGCopaxone 20 mg
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
DRUGPlovamer acetate 3 mg
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
DRUGPlovamer acetate 10 mg
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
DRUGPlovamer acetate 20 mg
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
Sponsors
EMD Serono
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, between the ages of 18 and 60 years * Subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject) * Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) (according to the 2010 McDonald MS diagnostic criteria) * Other protocol defined inclusion criteria could apply
Exclusion criteria
* Any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing * Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI * Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed) * Contraindication to Copaxone use * Other protocol defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline , Week 12, 24, 28, 32, 36, 40 | Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Remaining Relapse-Free | Baseline up to Week 40 | 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. |
| Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Weeks 12, 24, 28, 32, 36, 40 | T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans. |
| Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Weeks 12, 24, 28, 32, 36,40 | New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans. |
| Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Weeks 12, 24, 28, 32, 36, 40 | New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs. |
| Mean Annualized Relapse Rate (ARR) | Baseline up to Week 40 | 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). |
| Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline, Weeks 12, 24, 28, 32, 36, 40 | Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan. |
| Time to First Relapse | Baseline up to Week 40 | 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. |
| Mean Change From Baseline in Brain Volume Per Subject | Baseline, Weeks 24, 28, 32, 36, 40 | Change from baseline in brain volume per subject was calculated using 5 series MRI scan. |
| Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline, Weeks 12, 24, 28, 32, 36, 40 | Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans. |
Countries
Bulgaria, Croatia, Czechia, Finland, Greece, Hungary, Italy, Mexico, Poland, Russia, Serbia, South Africa, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Plovamer Acetate 0.5 Milligram (mg) 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. | 51 |
| Plovamer Acetate 3 mg Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months. | 49 |
| Plovamer Acetate 10 mg Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months. | 52 |
| Plovamer Acetate 20 mg Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months. | 52 |
| Copaxone 20 mg Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months. | 50 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 3 | 4 | 3 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Other | 47 | 46 | 48 | 45 | 45 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | Plovamer Acetate 0.5 Milligram (mg) | Plovamer Acetate 3 mg | Plovamer Acetate 10 mg | Plovamer Acetate 20 mg | Copaxone 20 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 39.2 years STANDARD_DEVIATION 10.73 | 40.7 years STANDARD_DEVIATION 9.54 | 41.1 years STANDARD_DEVIATION 10.83 | 40.4 years STANDARD_DEVIATION 9.53 | 41.8 years STANDARD_DEVIATION 11.61 | 40.6 years STANDARD_DEVIATION 10.43 |
| Sex: Female, Male Female | 38 Participants | 37 Participants | 39 Participants | 37 Participants | 26 Participants | 177 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 13 Participants | 15 Participants | 24 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 51 | 34 / 49 | 38 / 52 | 41 / 52 | 42 / 50 |
| serious Total, serious adverse events | 2 / 51 | 0 / 49 | 2 / 52 | 3 / 52 | 0 / 50 |
Outcome results
Primary
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
Population: Intent to Treat (ITT) analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 1.7 lesions per subjects per scan | Standard Deviation 2.75 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions per subjects per scan | — |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline (n=44,45,42,41,44) | 1.5 lesions per subjects per scan | Standard Deviation 2.93 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 1.0 lesions per subjects per scan | Standard Deviation 1.41 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 1.5 lesions per subjects per scan | Standard Deviation 2.53 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 0.0 lesions per subjects per scan | — |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.7 lesions per subjects per scan | Standard Deviation 3.28 |
| Plovamer Acetate 3 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | NA lesions per subjects per scan | — |
| Plovamer Acetate 3 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.2 lesions per subjects per scan | Standard Deviation 0.41 |
| Plovamer Acetate 3 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | NA lesions per subjects per scan | — |
| Plovamer Acetate 3 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.3 lesions per subjects per scan | Standard Deviation 3.55 |
| Plovamer Acetate 3 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline (n=44,45,42,41,44) | 1.6 lesions per subjects per scan | Standard Deviation 4.12 |
| Plovamer Acetate 3 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 0.9 lesions per subjects per scan | Standard Deviation 2.33 |
| Plovamer Acetate 3 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.4 lesions per subjects per scan | Standard Deviation 0.92 |
| Plovamer Acetate 10 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline (n=44,45,42,41,44) | 1.0 lesions per subjects per scan | Standard Deviation 2.43 |
| Plovamer Acetate 10 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.2 lesions per subjects per scan | Standard Deviation 2.4 |
| Plovamer Acetate 10 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions per subjects per scan | — |
| Plovamer Acetate 10 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 1.0 lesions per subjects per scan | Standard Deviation 1.41 |
| Plovamer Acetate 10 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.5 lesions per subjects per scan | Standard Deviation 1.2 |
| Plovamer Acetate 10 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.8 lesions per subjects per scan | Standard Deviation 1.72 |
| Plovamer Acetate 10 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 1.5 lesions per subjects per scan | Standard Deviation 4.14 |
| Plovamer Acetate 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions per subjects per scan | — |
| Plovamer Acetate 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline (n=44,45,42,41,44) | 2.3 lesions per subjects per scan | Standard Deviation 5.65 |
| Plovamer Acetate 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.5 lesions per subjects per scan | Standard Deviation 3.7 |
| Plovamer Acetate 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 1.1 lesions per subjects per scan | Standard Deviation 1.92 |
| Plovamer Acetate 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 2.0 lesions per subjects per scan | Standard Deviation 4 |
| Plovamer Acetate 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 1.8 lesions per subjects per scan | Standard Deviation 3.33 |
| Plovamer Acetate 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 1.3 lesions per subjects per scan | Standard Deviation 2.31 |
| Copaxone 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.9 lesions per subjects per scan | Standard Deviation 1.89 |
| Copaxone 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 16.0 lesions per subjects per scan | — |
| Copaxone 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 7.3 lesions per subjects per scan | Standard Deviation 12.7 |
| Copaxone 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 0.6 lesions per subjects per scan | Standard Deviation 1.46 |
| Copaxone 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.7 lesions per subjects per scan | Standard Deviation 4.51 |
| Copaxone 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline (n=44,45,42,41,44) | 2.5 lesions per subjects per scan | Standard Deviation 5.12 |
| Copaxone 20 mg | Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 1.2 lesions per subjects per scan | Standard Deviation 3.67 |
Secondary
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
Population: Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plovamer Acetate 0.5 Milligram (mg) | Mean Annualized Relapse Rate (ARR) | 0.3 percent relapse | Standard Deviation 0.88 |
| Plovamer Acetate 3 mg | Mean Annualized Relapse Rate (ARR) | 0.2 percent relapse | Standard Deviation 0.62 |
| Plovamer Acetate 10 mg | Mean Annualized Relapse Rate (ARR) | 0.2 percent relapse | Standard Deviation 0.76 |
| Plovamer Acetate 20 mg | Mean Annualized Relapse Rate (ARR) | 0.2 percent relapse | Standard Deviation 0.88 |
| Copaxone 20 mg | Mean Annualized Relapse Rate (ARR) | 0.2 percent relapse | Standard Deviation 0.92 |
Secondary
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
Population: The Outcome Measure was not derived due to early termination of the study.
Secondary
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
Population: ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 40: (n=0,0,0,1,1) | NA cubic millimeter (mm^3) | — |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 32: (n=4,6,8,10,9) | -0.085 cubic millimeter (mm^3) | Standard Deviation 0.2765 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline: (n=44,45,42,41,44) | 0.182 cubic millimeter (mm^3) | Standard Deviation 0.4212 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 24: (n=16,17,20,18,19) | 0.053 cubic millimeter (mm^3) | Standard Deviation 0.1705 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 36: (n=0,0,1,3,3) | NA cubic millimeter (mm^3) | — |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 28: (n=9,11,12,12,13) | 0.224 cubic millimeter (mm^3) | Standard Deviation 0.2948 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 12: (n=44,45,42,41,44) | 0.037 cubic millimeter (mm^3) | Standard Deviation 0.3982 |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 40: (n=0,0,0,1,1) | NA cubic millimeter (mm^3) | — |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 12: (n=44,45,42,41,44) | -0.007 cubic millimeter (mm^3) | Standard Deviation 0.6019 |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline: (n=44,45,42,41,44) | 0.209 cubic millimeter (mm^3) | Standard Deviation 0.6325 |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 36: (n=0,0,1,3,3) | NA cubic millimeter (mm^3) | — |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 32: (n=4,6,8,10,9) | -0.102 cubic millimeter (mm^3) | Standard Deviation 0.2691 |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 28: (n=9,11,12,12,13) | 0.067 cubic millimeter (mm^3) | Standard Deviation 0.464 |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 24: (n=16,17,20,18,19) | 0.352 cubic millimeter (mm^3) | Standard Deviation 1.4308 |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 28: (n=9,11,12,12,13) | 0.057 cubic millimeter (mm^3) | Standard Deviation 0.5728 |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 32: (n=4,6,8,10,9) | -0.135 cubic millimeter (mm^3) | Standard Deviation 0.6305 |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 36: (n=0,0,1,3,3) | 0.321 cubic millimeter (mm^3) | — |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 40: (n=0,0,0,1,1) | NA cubic millimeter (mm^3) | — |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline: (n=44,45,42,41,44) | 0.138 cubic millimeter (mm^3) | Standard Deviation 0.3577 |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 12: (n=44,45,42,41,44) | 0.189 cubic millimeter (mm^3) | Standard Deviation 0.8406 |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 24: (n=16,17,20,18,19) | 0.060 cubic millimeter (mm^3) | Standard Deviation 0.4858 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 12: (n=44,45,42,41,44) | -0.190 cubic millimeter (mm^3) | Standard Deviation 1.0389 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 32: (n=4,6,8,10,9) | -0.988 cubic millimeter (mm^3) | Standard Deviation 1.98 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 28: (n=9,11,12,12,13) | -0.796 cubic millimeter (mm^3) | Standard Deviation 1.7779 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 24: (n=16,17,20,18,19) | -0.591 cubic millimeter (mm^3) | Standard Deviation 1.491 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 36: (n=0,0,1,3,3) | -1.881 cubic millimeter (mm^3) | Standard Deviation 3.4679 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 40: (n=0,0,0,1,1) | 0.000 cubic millimeter (mm^3) | — |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline: (n=44,45,42,41,44) | 0.508 cubic millimeter (mm^3) | Standard Deviation 1.1981 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 24: (n=16,17,20,18,19) | -0.250 cubic millimeter (mm^3) | Standard Deviation 0.5393 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline: (n=44,45,42,41,44) | 0.264 cubic millimeter (mm^3) | Standard Deviation 0.5707 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 36: (n=0,0,1,3,3) | 0.834 cubic millimeter (mm^3) | Standard Deviation 2.1816 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 28: (n=9,11,12,12,13) | -0.257 cubic millimeter (mm^3) | Standard Deviation 0.698 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 12: (n=44,45,42,41,44) | 0.023 cubic millimeter (mm^3) | Standard Deviation 0.5794 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 32: (n=4,6,8,10,9) | 0.031 cubic millimeter (mm^3) | Standard Deviation 0.8312 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 40: (n=0,0,0,1,1) | 2.180 cubic millimeter (mm^3) | — |
Secondary
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
Population: ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline (n=44,45,42,41,44) | 12.240 cubic millimeter (mm^3) | Standard Deviation 14.6956 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 28: (n=9,11,12,12,13) | 0.016 cubic millimeter (mm^3) | Standard Deviation 3.2248 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 24: (n=16,17,20,18,19) | -0.179 cubic millimeter (mm^3) | Standard Deviation 2.2741 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 40: (n=0,0,0,1,1) | NA cubic millimeter (mm^3) | — |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 36: (n=0,0,1,3,3) | NA cubic millimeter (mm^3) | — |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 32: (n=4,6,8,10,9) | 0.874 cubic millimeter (mm^3) | Standard Deviation 2.4859 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 12: (n=44,45,42,41,44) | 0.443 cubic millimeter (mm^3) | Standard Deviation 2.2414 |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 40: (n=0,0,0,1,1) | NA cubic millimeter (mm^3) | — |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline (n=44,45,42,41,44) | 13.482 cubic millimeter (mm^3) | Standard Deviation 19.0522 |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 12: (n=44,45,42,41,44) | 0.397 cubic millimeter (mm^3) | Standard Deviation 1.0399 |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 24: (n=16,17,20,18,19) | 0.871 cubic millimeter (mm^3) | Standard Deviation 2.7803 |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 28: (n=9,11,12,12,13) | 0.858 cubic millimeter (mm^3) | Standard Deviation 3.0417 |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 32: (n=4,6,8,10,9) | 0.163 cubic millimeter (mm^3) | Standard Deviation 1.2524 |
| Plovamer Acetate 3 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 36: (n=0,0,1,3,3) | NA cubic millimeter (mm^3) | — |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 36: (n=0,0,1,3,3) | 1.236 cubic millimeter (mm^3) | — |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 12: (n=44,45,42,41,44) | 0.686 cubic millimeter (mm^3) | Standard Deviation 2.4894 |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 32: (n=4,6,8,10,9) | -0.106 cubic millimeter (mm^3) | Standard Deviation 1.3423 |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 40: (n=0,0,0,1,1) | NA cubic millimeter (mm^3) | — |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 28: (n=9,11,12,12,13) | 0.306 cubic millimeter (mm^3) | Standard Deviation 1.1945 |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 24: (n=16,17,20,18,19) | 0.113 cubic millimeter (mm^3) | Standard Deviation 1.2011 |
| Plovamer Acetate 10 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline (n=44,45,42,41,44) | 11.364 cubic millimeter (mm^3) | Standard Deviation 16.0282 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 32: (n=4,6,8,10,9) | -3.246 cubic millimeter (mm^3) | Standard Deviation 9.3533 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 28: (n=9,11,12,12,13) | -2.610 cubic millimeter (mm^3) | Standard Deviation 8.3108 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 40: (n=0,0,0,1,1) | -29.965 cubic millimeter (mm^3) | — |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 24: (n=16,17,20,18,19) | -1.734 cubic millimeter (mm^3) | Standard Deviation 6.8085 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline (n=44,45,42,41,44) | 9.518 cubic millimeter (mm^3) | Standard Deviation 13.2248 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 36: (n=0,0,1,3,3) | -10.324 cubic millimeter (mm^3) | Standard Deviation 17.2227 |
| Plovamer Acetate 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 12: (n=44,45,42,41,44) | -0.200 cubic millimeter (mm^3) | Standard Deviation 4.5312 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Baseline (n=44,45,42,41,44) | 11.616 cubic millimeter (mm^3) | Standard Deviation 15.496 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 28: (n=9,11,12,12,13) | -1.379 cubic millimeter (mm^3) | Standard Deviation 3.4251 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 36: (n=0,0,1,3,3) | -4.433 cubic millimeter (mm^3) | Standard Deviation 4.6895 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 12: (n=44,45,42,41,44) | 0.060 cubic millimeter (mm^3) | Standard Deviation 1.3886 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 32: (n=4,6,8,10,9) | -1.867 cubic millimeter (mm^3) | Standard Deviation 3.6432 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 24: (n=16,17,20,18,19) | -0.907 cubic millimeter (mm^3) | Standard Deviation 2.5627 |
| Copaxone 20 mg | Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Change at Week 40: (n=0,0,0,1,1) | -10.661 cubic millimeter (mm^3) | — |
Secondary
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
Population: ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 4.5 lesions/subject/scan | Standard Deviation 7.41 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 3.1 lesions/subject/scan | Standard Deviation 5.61 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 1.3 lesions/subject/scan | Standard Deviation 2.45 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 1.4 lesions/subject/scan | Standard Deviation 2.19 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 3 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | NA lesions/subject/scan | — |
| Plovamer Acetate 3 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | NA lesions/subject/scan | — |
| Plovamer Acetate 3 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 2.6 lesions/subject/scan | Standard Deviation 4.99 |
| Plovamer Acetate 3 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.2 lesions/subject/scan | Standard Deviation 0.4 |
| Plovamer Acetate 3 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.2 lesions/subject/scan | Standard Deviation 0.41 |
| Plovamer Acetate 3 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 1.8 lesions/subject/scan | Standard Deviation 3.35 |
| Plovamer Acetate 10 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.3 lesions/subject/scan | Standard Deviation 0.71 |
| Plovamer Acetate 10 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 0.5 lesions/subject/scan | Standard Deviation 0.71 |
| Plovamer Acetate 10 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 2.7 lesions/subject/scan | Standard Deviation 4.5 |
| Plovamer Acetate 10 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.8 lesions/subject/scan | Standard Deviation 1.69 |
| Plovamer Acetate 10 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 2.3 lesions/subject/scan | Standard Deviation 4.91 |
| Plovamer Acetate 10 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 2.4 lesions/subject/scan | Standard Deviation 4.12 |
| Plovamer Acetate 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 3.4 lesions/subject/scan | Standard Deviation 6.03 |
| Plovamer Acetate 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 2.5 lesions/subject/scan | Standard Deviation 5.05 |
| Plovamer Acetate 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 1.7 lesions/subject/scan | Standard Deviation 2.89 |
| Plovamer Acetate 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 4.1 lesions/subject/scan | Standard Deviation 7.45 |
| Copaxone 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 4.3 lesions/subject/scan | Standard Deviation 7.51 |
| Copaxone 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.8 lesions/subject/scan | Standard Deviation 2.15 |
| Copaxone 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 1.7 lesions/subject/scan | Standard Deviation 3.45 |
| Copaxone 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 13.0 lesions/subject/scan | — |
| Copaxone 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.9 lesions/subject/scan | Standard Deviation 2.32 |
| Copaxone 20 mg | Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 4.0 lesions/subject/scan | Standard Deviation 8.59 |
Secondary
Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan
T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.
Time frame: Weeks 12, 24, 28, 32, 36, 40
Population: ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.7 lesions/subject/scan | Standard Deviation 3.26 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 1.5 lesions/subject/scan | Standard Deviation 2.53 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 1.2 lesions/subject/scan | Standard Deviation 2.15 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.8 lesions/subject/scan | Standard Deviation 1.1 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 3 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | NA lesions/subject/scan | — |
| Plovamer Acetate 3 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | NA lesions/subject/scan | — |
| Plovamer Acetate 3 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.2 lesions/subject/scan | Standard Deviation 3.54 |
| Plovamer Acetate 3 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.1 lesions/subject/scan | Standard Deviation 0.3 |
| Plovamer Acetate 3 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.2 lesions/subject/scan | Standard Deviation 0.41 |
| Plovamer Acetate 3 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 0.9 lesions/subject/scan | Standard Deviation 2.33 |
| Plovamer Acetate 10 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.4 lesions/subject/scan | Standard Deviation 1.33 |
| Plovamer Acetate 10 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 0.5 lesions/subject/scan | Standard Deviation 0.71 |
| Plovamer Acetate 10 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.2 lesions/subject/scan | Standard Deviation 2.26 |
| Plovamer Acetate 10 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.5 lesions/subject/scan | Standard Deviation 1.13 |
| Plovamer Acetate 10 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 1.4 lesions/subject/scan | Standard Deviation 3.56 |
| Plovamer Acetate 10 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 1.5 lesions/subject/scan | Standard Deviation 2.95 |
| Plovamer Acetate 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 1.0 lesions/subject/scan | Standard Deviation 1.94 |
| Plovamer Acetate 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 1.8 lesions/subject/scan | Standard Deviation 3.83 |
| Plovamer Acetate 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 1.0 lesions/subject/scan | Standard Deviation 1.73 |
| Plovamer Acetate 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.3 lesions/subject/scan | Standard Deviation 2.99 |
| Copaxone 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 5.7 lesions/subject/scan | Standard Deviation 9.81 |
| Copaxone 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.5 lesions/subject/scan | Standard Deviation 1.33 |
| Copaxone 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 0.5 lesions/subject/scan | Standard Deviation 1.26 |
| Copaxone 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 16.0 lesions/subject/scan | — |
| Copaxone 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.6 lesions/subject/scan | Standard Deviation 1.67 |
| Copaxone 20 mg | Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.6 lesions/subject/scan | Standard Deviation 4.31 |
Secondary
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
Population: ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 2.8 lesions/subject/scan | Standard Deviation 6.48 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 2.0 lesions/subject/scan | Standard Deviation 4.8 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.6 lesions/subject/scan | Standard Deviation 1.26 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 2.0 lesions/subject/scan | Standard Deviation 3.39 |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 0.5 Milligram (mg) | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 3 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 0.8 lesions/subject/scan | Standard Deviation 1.55 |
| Plovamer Acetate 3 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 40: (n=1,0,1,1,1) | NA lesions/subject/scan | — |
| Plovamer Acetate 3 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.2 lesions/subject/scan | Standard Deviation 0.6 |
| Plovamer Acetate 3 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.2 lesions/subject/scan | Standard Deviation 0.41 |
| Plovamer Acetate 3 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 36: (n=1,0,2,3,3) | NA lesions/subject/scan | — |
| Plovamer Acetate 3 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.8 lesions/subject/scan | Standard Deviation 3.97 |
| Plovamer Acetate 10 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.6 lesions/subject/scan | Standard Deviation 1.56 |
| Plovamer Acetate 10 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 10 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.8 lesions/subject/scan | Standard Deviation 1.3 |
| Plovamer Acetate 10 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 0.0 lesions/subject/scan | Standard Deviation 0 |
| Plovamer Acetate 10 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 0.8 lesions/subject/scan | Standard Deviation 1.83 |
| Plovamer Acetate 10 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 1.4 lesions/subject/scan | Standard Deviation 2.21 |
| Plovamer Acetate 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 0.0 lesions/subject/scan | — |
| Plovamer Acetate 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.5 lesions/subject/scan | Standard Deviation 1 |
| Plovamer Acetate 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.7 lesions/subject/scan | Standard Deviation 1.25 |
| Plovamer Acetate 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 0.7 lesions/subject/scan | Standard Deviation 1.15 |
| Plovamer Acetate 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 2.6 lesions/subject/scan | Standard Deviation 5.24 |
| Plovamer Acetate 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 1.3 lesions/subject/scan | Standard Deviation 2.89 |
| Copaxone 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 36: (n=1,0,2,3,3) | 1.7 lesions/subject/scan | Standard Deviation 2.89 |
| Copaxone 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 32: (n=5,6,9,10,9) | 0.3 lesions/subject/scan | Standard Deviation 0.71 |
| Copaxone 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 24: (n=17,17,21,18,19) | 0.8 lesions/subject/scan | Standard Deviation 1.75 |
| Copaxone 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 12: (n=44,45,43,41,44) | 2.6 lesions/subject/scan | Standard Deviation 5.13 |
| Copaxone 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 28: (n=10,11,13,12,13) | 0.4 lesions/subject/scan | Standard Deviation 1.39 |
| Copaxone 20 mg | Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan | Week 40: (n=1,0,1,1,1) | 11.0 lesions/subject/scan | — |
Secondary
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
Population: Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Plovamer Acetate 0.5 Milligram (mg) | Percentage of Subjects Remaining Relapse-Free | 86.3 percent subjects |
| Plovamer Acetate 3 mg | Percentage of Subjects Remaining Relapse-Free | 89.8 percent subjects |
| Plovamer Acetate 10 mg | Percentage of Subjects Remaining Relapse-Free | 94.2 percent subjects |
| Plovamer Acetate 20 mg | Percentage of Subjects Remaining Relapse-Free | 94.2 percent subjects |
| Copaxone 20 mg | Percentage of Subjects Remaining Relapse-Free | 90.0 percent subjects |
Secondary
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
Population: The Outcome Measure was not derived due to early termination of the study.