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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) (GLOW)

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ClinicalTrials.gov Identifier: NCT01578785
Recruitment Status : Terminated
First Posted : April 17, 2012
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Relapsing-Remitting Multiple Sclerosis
Interventions Drug: Glatiramer Acetate
Drug: Placebo
Enrollment 178
Recruitment Details  
Pre-assignment Details Two hundred seventy-four patients were screened and 178 randomized into the study in a 1:2 treatment arm ratio.
Arm/Group Title Placebo GA 20 MG/0.5 ML
Hide Arm/Group Description Placebo solution in prefilled syringe for subcutaneous injection once daily. Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
Period Title: Overall Study
Started 59 119
Completed 0 0
Not Completed 59 119
Reason Not Completed
Withdrawal by Subject             0             1
Study terminated by sponsor             59             118
Arm/Group Title Placebo GA 20 mg/0.5 ml Total
Hide Arm/Group Description Placebo solution in prefilled syringe for subcutaneous injection once daily. Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily. Total of all reporting groups
Overall Number of Baseline Participants 59 119 178
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
AgeContinuous Number Analyzed 59 participants 119 participants 178 participants
37.7  (9.13) 38.9  (8.36) 38.5  (8.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 119 participants 178 participants
Female
45
  76.3%
87
  73.1%
132
  74.2%
Male
14
  23.7%
32
  26.9%
46
  25.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 119 participants 178 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
59
 100.0%
119
 100.0%
178
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 119 participants 178 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.7%
1
   0.8%
2
   1.1%
White
58
  98.3%
118
  99.2%
176
  98.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 119 participants 178 participants
Bulgaria 7 22 29
Bosnia and Herzegovina 6 11 17
Belarus 4 4 8
Estonia 0 1 1
Georgia 6 8 14
Croatia 7 18 25
Poland 19 35 54
Romania 9 19 28
USA 1 1 2
1.Primary Outcome
Title The Annualized Relapse Rate During the Placebo Controlled Period
Hide Description 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.
Time Frame Day 1 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population was planned. However analysis was not performed due to early termination of the study.
Arm/Group Title Placebo GA 20 MG/0.5 ML
Hide Arm/Group Description:
Placebo solution in prefilled syringe for subcutaneous injection once daily.
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period)
Hide Description Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.
Time Frame Day 1 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population was planned. However analysis was not performed due to early termination of the study.
Arm/Group Title Placebo GA 20 MG/0.5 ML
Hide Arm/Group Description:
Placebo solution in prefilled syringe for subcutaneous injection once daily.
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period)
Hide Description Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.
Time Frame Day 1 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population was planned. However analysis was not performed due to early termination of the study.
Arm/Group Title Placebo GA 20 MG/0.5 ML
Hide Arm/Group Description:
Placebo solution in prefilled syringe for subcutaneous injection once daily.
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume
Hide Description Brain atrophy was defined by the percent brain volume change from baseline to Month 12
Time Frame Day 1 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population was planned. However analysis was not performed due to early termination of the study.
Arm/Group Title Placebo GA 20 MG/0.5 ML
Hide Arm/Group Description:
Placebo solution in prefilled syringe for subcutaneous injection once daily.
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Day 1 up to day 127
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Ga 20 mg/0.5 ml
Hide Arm/Group Description Placebo solution in prefilled syringe for subcutaneous injection once daily. Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
All-Cause Mortality
Placebo Ga 20 mg/0.5 ml
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Ga 20 mg/0.5 ml
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/59 (0.00%)      0/119 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Ga 20 mg/0.5 ml
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/59 (1.69%)      22/119 (18.49%)    
General disorders     
Injection site erythema *  1/59 (1.69%)  1 13/119 (10.92%)  13
Injection site pain *  1/59 (1.69%)  1 12/119 (10.08%)  12
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
EMail: ustevatrials@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01578785     History of Changes
Other Study ID Numbers: GA-MS-302
2011-005550-57 ( EudraCT Number )
First Submitted: March 13, 2012
First Posted: April 17, 2012
Results First Submitted: February 19, 2014
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014