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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier:
NCT01167426
First received: July 20, 2010
Last updated: August 8, 2013
Last verified: August 2012
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: Glatiramer Acetate 20 mg/0.5 mL
Drug: Glatiramer acetate 20 mg/0.5 mL
Phase 3

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 148
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167426

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

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier: NCT01167426     History of Changes
Other Study ID Numbers: PM034
Study First Received: July 20, 2010
Results First Received: August 17, 2012
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Relapsing Remitting Multiple Sclerosis
RRMS
Clinically Isolated Syndrome
CIS
Copaxone
glatiramer acetate
Autoject 2

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 17, 2014