Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients (ENCORE)
This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.
Drug: Glatiramer Acetate 20 mg/0.5 mL
Drug: Glatiramer acetate 20 mg/0.5 mL
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.|
- 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). ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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).
|Study Start Date:||July 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
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.
The study will consist of a 2 week treatment period with participants injecting their current therapy of Copaxone 20 mg/1.0 mL glatiramer acetate utilizing an autoject 2. All participants will then roll over to the new formulation of 20 mg/0.5 mL glatiramer acetate with an autoject 2 device for a 4 week treatment period. Patient satisfaction will be evaluated using an Experience Questionnaire throughout the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167426
|Study Director:||Tom Smith, MD||Teva Neuroscience, Inc.|