Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients. (ENCORE)
This study has been completed.
Sponsor:
Teva Neuroscience, Inc.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Neuroscience, Inc. )
ClinicalTrials.gov Identifier:
NCT01167426
First received: July 20, 2010
Last updated: August 22, 2011
Last verified: August 2011
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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 20mg/1.0 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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- Single group composite mean scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The Satisfaction with Injection Experience questionnaire utilizes a two-week recall period and a 5-point rating scale where the response options range from "strongly disagree" to "strongly agree".
Secondary Outcome Measures:
- Single Group Categorical preference rating [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The Injection Experience Preference Questionnaire utilizes a 5-level preference scale where the response options are Question 1."strongly prefer first experience (first 2 weeks)," Question 2. "somewhat prefer first experience (first 2 weeks)," Question 3. "no preference," Question 4. "somewhat prefer second experience (past 2 weeks)," Question 5. "strongly prefer second experience (past 2 weeks)." Questions 1&2 will be combined and questions 4&5 will be combined, then totals will be analyzed to determine overall preference.
| 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 |
|---|---|
|
20 mg/1.0 mL Glatiramer Acetate
20 mg/1.0 mL formulation of Glatiramer Acetate (GA) utilizing the autoject 2 for glass syringe at Visit 2 and the 20 mg/0.5 mL formulation of GA utilizing the autoject 2 20 mg/0.5 mL device at Visit 4 to evaluate overall injection satisfaction. Patients used their own supply of Glatiramer Acetate 20 mg/1.0 mL.
|
Drug: Glatiramer Acetate 20mg/1.0 mL
20 mg/1.0 mL formulation of GA utilizing the autoject 2 for glass syringe for the first 2 weeks and the 20 mg/0.5 mL formulation of GA utilizing the autoject 2 for the remaining 4 visits. Patients used their own supply of Glatiramer Acetate 20mg/1.0 mL.
Other Name: Copaxone®
|
|
Active Comparator: 20 mg/0.5 mL Glatiramer Acetate
Glatiramer Acetate 20 mg/0.5 mL administered by subcutaneous injection once daily for a 4 week treatment period
|
Drug: Glatiramer Acetate 20 mg/0.5 mL
20 mg/1.0 mL formulation of GA utilizing the autoject 2 for glass syringe for the first 2 weeks and the 20 mg/0.5 mL formulation of GA utilizing the autoject 2 for the remaining 4 visits.
Other Name: Copaxone®
|
Detailed Description:
The study will consist of a 2 week treatment period with patients injecting their current therapy of Copaxone 20mg/1.0mL GA utilizing an autoject 2. All patients will then roll over to the new formulation of 20mg/0.5mL GA with an autoject 2 device for a 4 week treatment period. At visit 4, patient satisfaction will be evaluated using an Experience Questionnaire.
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 RRMS or CIS
- Currently injecting GA 20mg/1.0mL 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 20mg/0.5mL formulation
Contacts and Locations 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 |
| Last Updated: | August 22, 2011 |
| 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 May 16, 2013