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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):
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )

Tracking Information
First Submitted Date  ICMJE July 20, 2010
First Posted Date  ICMJE July 22, 2010
Results First Submitted Date  ICMJE August 17, 2012
Results First Posted Date  ICMJE October 17, 2013
Last Update Posted Date October 17, 2013
Study Start Date  ICMJE July 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2010)
Difference in composite mean scores [ Time Frame: 5 months ]
as measured by the Satisfaction with Injection Experience question
Change History Complete list of historical versions of study NCT01167426 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2010)
Categorical preference rating [ Time Frame: 5 months ]
as measured by the Injection Experience Preference questions
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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).
Interventions:
  • Drug: Glatiramer Acetate 20 mg/0.5 mL
  • Drug: Glatiramer acetate 20 mg/0.5 mL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2011)
148
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2010)
141
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01167426
Other Study ID Numbers  ICMJE PM034
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
Study Sponsor  ICMJE Teva Neuroscience, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tom Smith, MD Teva Neuroscience, Inc.
PRS Account Teva Pharmaceutical Industries
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP