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
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Glatiramer Acetate 20 mg/0.5 mL Drug: Glatiramer acetate 20 mg/0.5 mL||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||148 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method.|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||December 2010|
Active Comparator: 20 mg/0.5 mL Glatiramer Acetate
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).
Drug: Glatiramer Acetate 20 mg/0.5 mL
20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe.
Other Name: Copaxone®Drug: Glatiramer acetate 20 mg/0.5 mL
20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.
- Change From Week 2 to Week 6 in Composite Score of Patient 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). ]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.
- Patient Injection Experience Preference [ Time Frame: Week 4 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167426
|Study Director:||Tom Smith, MD||Teva Neuroscience, Inc.|