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

Phase 3

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Glatiramer acetate 20 mg/0.5 mL

• Registration Number: NCT01167426
• Lead Sponsor: Teva Neuroscience, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Status Verified: 2012-08
• Results First Submitted: 2012-08-17
• Results First Submitted QC: 2013-08-08
• Last Update Submitted: 2013-08-08
• Results First Posted: 2013-10-17
• Last Update Posted: 2013-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Patients ≥ 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS)
• Currently injecting glatiramer acetate 20 mg/1.0 mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject 2 for glass syringe for a minimum of 75% of daily injections
• Willing and able to complete all procedures and evaluations related to the study
• Willing to continue to follow usual injection site preparation and routine adjunctive local injection site reactions (LISR) management techniques
• Willing and able to provide written informed consent

Exclusion Criteria

• Currently using or treated with another immunomodulating therapy (IMT) in conjunction with GA in the 30 days prior to screening for this study
• Currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study
• Pregnant or planning pregnancy or breastfeeding
• Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.) either currently or in the past 30 days prior to screening for this study
• Any other medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the Investigator
• Unwilling to perform all daily injections with an autoject 2 device
• Previous participation in any study evaluating the new 20 mg/0.5 mL formulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
20 mg/0.5 mL Glatiramer Acetate	Glatiramer acetate 20 mg/0.5 mL	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).

Primary Outcome Measures

Name	Time	Method
Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience	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.

Secondary Outcome Measures

Name	Time	Method
Patient Injection Experience Preference	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).