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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):

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Non-Randomized
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
Primary Completion Date : November 2010
Study Completion Date : December 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Sponsors and Collaborators
Teva Neuroscience, Inc.
Investigators
Study Director: Tom Smith, MD Teva Neuroscience, Inc.
More Information

Responsible Party: Teva Neuroscience, Inc.
ClinicalTrials.gov Identifier: NCT01167426     History of Changes
Other Study ID Numbers: PM034
First Posted: July 22, 2010    Key Record Dates
Results First Posted: October 17, 2013
Last Update Posted: October 17, 2013
Last Verified: August 2012

Keywords provided by Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. ):
Relapsing Remitting Multiple Sclerosis
RRMS
Clinically Isolated Syndrome
CIS
Copaxone
glatiramer acetate
Autoject 2

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Glatiramer Acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents