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Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).

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ClinicalTrials.gov Identifier: NCT00337779
Recruitment Status : Completed
First Posted : June 16, 2006
Results First Posted : May 14, 2010
Last Update Posted : October 10, 2011
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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Brief Summary:
Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties. The study treatment duration is 12 months.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Glatiramer Acetate (GA) 40 mg Drug: glatiramer acetate 20 mg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to That of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With Relapsing Remitting (R-R) Multiple Sclerosis (MS)
Study Start Date : August 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: glatiramer acetate 40 mg Drug: Glatiramer Acetate (GA) 40 mg
Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months
Other Name: Copaxone®
Active Comparator: glatiramer acetate 20 mg Drug: glatiramer acetate 20 mg
Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months
Other Name: Copaxone®


Outcome Measures
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Primary Outcome Measures :
  1. The Rate of Confirmed Relapses During the Double-blind Phase (12 Months). [ Time Frame: 12 months ]
    A confirmed relapse is defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities. This change in clinical state must last at least 48 hours and be immediately preceded by an improving neurological state of at least thirty (30) days from onset of previous relapse.


Secondary Outcome Measures :
  1. The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan. [ Time Frame: 12 months ]
    The analysis of this endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression including the number of T1 Gd-enhancing lesions at baseline, the volume of T2 lesions at baseline and (pooled) center as covariates.

  2. The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below). [ Time Frame: 12 months ]
    The Frequent MRI Cohort was a subset of subjects consisting of 234 subjects, for whom MRI scans were performed at months 0 (baseline), 1, 2, 3, 6, 9 and 12. Analysis of the endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression with an "offset" variable employing the log of the porportion of the number of available post-baseline scans to adjust for missing MRI scans (if any) and including the number of T1 Gd-enhancing lesions at baseline and (pooled) center as covariates.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of confirmed and documented MS defined by the Revised McDonald criteria.
  2. Subjects must be of the relapsing-remitting (R-R) type.
  3. Subject has experienced prior to screening at least one documented relapse in 12 months or at least 2 documented relapses in the 24 months or one documented relapse between 12 - 24 months with at least 1 documented T1-Gd enhancing lesion in the MRI performed 12 months prior screening.
  4. Disease duration for at least 6 months.
  5. Ambulatory with converted Kurtzke EDSS score of 0 - 5.
  6. Relapse free and stable neurological condition at least for 30 days prior screening.
  7. Age - 18-55 (inclusive)

Exclusion Criteria:

  1. Previous use of Copaxone (glatiramer acetate)
  2. Treatment with corticosteroids within 30 days prior screening or between screening and baseline.
  3. Chronic corticosteroids treatment - more than 30 consecutive days.
  4. Subject with any clinically significant or unstable medical condition.
  5. Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
  6. Known history of sensitivity to Gadolinium and inability to successfully undergo MRI scanning.
Contacts and Locations
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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): NCT00337779


Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Chair: Chen Duksin, MD Teva Pharmaceutical Industries, Ltd.
Principal Investigator: Giancarlo Comi, Prof Istituto Scientifico Fondazione Centro S. Raffaele
More Information
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT00337779    
Other Study ID Numbers: GA/9016 (FORTE)
First Posted: June 16, 2006    Key Record Dates
Results First Posted: May 14, 2010
Last Update Posted: October 10, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Glatiramer Acetate
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents