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Trial record 7 of 119 for:    COP1

Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients (ENCORE)

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ClinicalTrials.gov Identifier: NCT01167426
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : October 17, 2013
Last Update Posted : October 17, 2013
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Multiple Sclerosis
Interventions Drug: Glatiramer Acetate 20 mg/0.5 mL
Drug: Glatiramer acetate 20 mg/0.5 mL
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glatiramer Acetate
Hide Arm/Group Description Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
Period Title: Overall Study
Started 148
Completed 138
Not Completed 10
Reason Not Completed
Lost to Follow-up             6
Protocol Violation             1
Withdrawal by Subject             2
Sponsor Decision             1
Arm/Group Title Glatiramer Acetate
Hide Arm/Group Description Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
Overall Number of Baseline Participants 148
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants
<=18 years
1
   0.7%
Between 18 and 65 years
140
  94.6%
>=65 years
7
   4.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants
48.1  (10.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants
Female
126
  85.1%
Male
22
  14.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants
Hispanic or Latino
4
   2.7%
Not Hispanic or Latino
144
  97.3%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants
White 141
Black or African American 3
Other 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 148 participants
148
Duration of Glatiramer Acetate  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants
4.823  (3.5539)
Duration of Multiple Sclerosis Disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants
10.167  (9.0643)
1.Primary Outcome
Title Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience
Hide Description The Satisfaction with Injection Experience questionnaire consists of 5 questions where participants are asked to rate their injection experience over the past 2 weeks on ease of use, bother, acceptability, confidence to inject and satisfaction. The response options range from "strongly disagree" (score = 1) to "strongly agree" (score = 5). The composite score of Satisfaction with Injection Experience is defined as the mean of the five Likert questions. The composite score ranges from 1.0 to 5.0, with a score of 5.0 representing the most satisfaction with injection experience and a score of 1.0 representing the least satisfaction with injection experience.
Time Frame Week 2 (prior to first injection with 20 mg/0.5 mL formulation), Week 6 (after 4 weeks of treatment with 20 mg/0.5 mL formulation).
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population consisted of of all patients who received at least one dose of study medication and had satisfaction data at time points 2 and 6 weeks, 2 and 4 weeks, or 2, 4 and 6 weeks.
Arm/Group Title Glatiramer Acetate
Hide Arm/Group Description:
Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
Overall Number of Participants Analyzed 139
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 4.1  (0.77)
Week 6 4.8  (0.46)
Change from Week 2 to Week 6 0.7  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glatiramer Acetate
Comments Comparison of Week 2 (20 mg/1.0 mL utilizing autoject 2 for glass syringe) to Week 6 (20 mg/0.5 mL utilizing the autoject 2 20 mg/0.5 mL).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon Signed-Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in mean ranks
Estimated Value 79.6
Estimation Comments Difference in mean ranks between Week 2 and Week 6
2.Secondary Outcome
Title Patient Injection Experience Preference
Hide Description The Injection Experience Preference Questionnaire utilizes a 5-level preference scale where participants were asked to compare their injection experience during the first 2 weeks (glatiramer acetate 20 mg/1 mL) with the past 2 weeks (glatiramer acetate 20 mg/0.5 mL). Response options were: 1. "strongly prefer first experience (first 2 weeks)"; 2. "somewhat prefer first experience (first 2 weeks)"; 3. "no preference"; 4. "somewhat prefer second experience (past 2 weeks)"; 5. "strongly prefer second experience (past 2 weeks)." Responses 1 and 2 were combined into a single category (prefers first experience) and responses 4 and 5 were combined into a single category (prefers second experience).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population with available data.
Arm/Group Title Glatiramer Acetate
Hide Arm/Group Description:
Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
Overall Number of Participants Analyzed 140
Measure Type: Number
Unit of Measure: participants
Prefers First Experience 9
No Preference 22
Prefers Second Experience 109
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glatiramer Acetate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Goodness-of-fit p-value comparing overall preference to expected frequencies of 33.3% in each category. That is, no preference across the full sample of patients in the study.
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description All patients who receive at least 1 dose of study medication were included in the Safety population. 148 patients were exposed to the 20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe and 142 patients were exposed to the 20 mg/0.5 mL formulation utilizing the autoject 2 20 mg/0.5 mL device.
 
Arm/Group Title Period 1: Glatiramer Acetate 20 mg/1.0 mL Period 2: Glatirimer Actetate
Hide Arm/Group Description Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1). Participants received once daily subcutaneous administration of glatiramer acetate 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
All-Cause Mortality
Period 1: Glatiramer Acetate 20 mg/1.0 mL Period 2: Glatirimer Actetate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Period 1: Glatiramer Acetate 20 mg/1.0 mL Period 2: Glatirimer Actetate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/148 (0.00%)   0/142 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Period 1: Glatiramer Acetate 20 mg/1.0 mL Period 2: Glatirimer Actetate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/148 (0.00%)   11/142 (7.75%) 
General disorders     
Injection site reaction  1  0/148 (0.00%)  11/142 (7.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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: Thomas Smith, MD
Organization: Teva Pharmaceuticals Medical Affairs
Phone: 816-508-5128
EMail: tom.smith@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier: NCT01167426     History of Changes
Other Study ID Numbers: PM034
First Submitted: July 20, 2010
First Posted: July 22, 2010
Results First Submitted: August 17, 2012
Results First Posted: October 17, 2013
Last Update Posted: October 17, 2013