Trial Outcomes & Findings for An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) (NCT NCT01578785)
NCT ID: NCT01578785
Last Updated: 2014-04-02
Results Overview
The total number of confirmed relapses during the placebo-controlled phase is divided by the sum of the number of days on study in the placebo-controlled phase and then multiplied by the number of days in the year to calculate the annualized relapse rate.
TERMINATED
PHASE3
178 participants
Day 1 up to Month 12
2014-04-02
Participant Flow
Two hundred seventy-four patients were screened and 178 randomized into the study in a 1:2 treatment arm ratio.
Participant milestones
| Measure |
Placebo
Placebo solution in prefilled syringe for subcutaneous injection once daily.
|
GA 20 MG/0.5 ML
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
119
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
59
|
119
|
Reasons for withdrawal
| Measure |
Placebo
Placebo solution in prefilled syringe for subcutaneous injection once daily.
|
GA 20 MG/0.5 ML
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Study terminated by sponsor
|
59
|
118
|
Baseline Characteristics
An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
Baseline characteristics by cohort
| Measure |
Placebo
n=59 Participants
Placebo solution in prefilled syringe for subcutaneous injection once daily.
|
GA 20 mg/0.5 ml
n=119 Participants
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
AgeContinuous
|
37.7 years
STANDARD_DEVIATION 9.13 • n=39 Participants
|
38.9 years
STANDARD_DEVIATION 8.36 • n=41 Participants
|
38.5 years
STANDARD_DEVIATION 8.62 • n=35 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=39 Participants
|
87 Participants
n=41 Participants
|
132 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=39 Participants
|
119 Participants
n=41 Participants
|
178 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=39 Participants
|
118 Participants
n=41 Participants
|
176 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Bulgaria
|
7 participants
n=39 Participants
|
22 participants
n=41 Participants
|
29 participants
n=35 Participants
|
|
Region of Enrollment
Bosnia and Herzegovina
|
6 participants
n=39 Participants
|
11 participants
n=41 Participants
|
17 participants
n=35 Participants
|
|
Region of Enrollment
Belarus
|
4 participants
n=39 Participants
|
4 participants
n=41 Participants
|
8 participants
n=35 Participants
|
|
Region of Enrollment
Estonia
|
0 participants
n=39 Participants
|
1 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Region of Enrollment
Georgia
|
6 participants
n=39 Participants
|
8 participants
n=41 Participants
|
14 participants
n=35 Participants
|
|
Region of Enrollment
Croatia
|
7 participants
n=39 Participants
|
18 participants
n=41 Participants
|
25 participants
n=35 Participants
|
|
Region of Enrollment
Poland
|
19 participants
n=39 Participants
|
35 participants
n=41 Participants
|
54 participants
n=35 Participants
|
|
Region of Enrollment
Romania
|
9 participants
n=39 Participants
|
19 participants
n=41 Participants
|
28 participants
n=35 Participants
|
|
Region of Enrollment
USA
|
1 participants
n=39 Participants
|
1 participants
n=41 Participants
|
2 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Month 12Population: Intent to treat population was planned. However analysis was not performed due to early termination of the study.
The total number of confirmed relapses during the placebo-controlled phase is divided by the sum of the number of days on study in the placebo-controlled phase and then multiplied by the number of days in the year to calculate the annualized relapse rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 up to Month 12Population: Intent to treat population was planned. However analysis was not performed due to early termination of the study.
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 up to Month 12Population: Intent to treat population was planned. However analysis was not performed due to early termination of the study.
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 up to Month 12Population: Intent to treat population was planned. However analysis was not performed due to early termination of the study.
Brain atrophy was defined by the percent brain volume change from baseline to Month 12
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Ga 20 mg/0.5 ml
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=59 participants at risk
Placebo solution in prefilled syringe for subcutaneous injection once daily.
|
Ga 20 mg/0.5 ml
n=119 participants at risk
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
|
|---|---|---|
|
General disorders
Injection site pain
|
1.7%
1/59 • Number of events 1 • Day 1 up to day 127
|
10.1%
12/119 • Number of events 12 • Day 1 up to day 127
|
|
General disorders
Injection site erythema
|
1.7%
1/59 • Number of events 1 • Day 1 up to day 127
|
10.9%
13/119 • Number of events 13 • Day 1 up to day 127
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER