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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Glatiramer Acetate 20 mg/0.5 mL
* Drug: Glatiramer acetate 20 mg/0.5 mL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 20 mg/0.5 mL Glatiramer Acetate<br>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<br>* 20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe.<br>* Other names: Copaxone®;Drug: Glatiramer acetate 20 mg/0.5 mL<br>* 20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience | 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. | 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Injection Experience Preference | 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). | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsing Remitting Multiple Sclerosis, RRMS, Clinically Isolated Syndrome, CIS, Copaxone, glatiramer acetate, Autoject 2