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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00337779
First received: June 14, 2006
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: Glatiramer Acetate (GA) 40 mg
Drug: glatiramer acetate 20 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The Rate of Confirmed Relapses During the Double-blind Phase (12 Months). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1155
Study Start Date: August 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337779

Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Chair: Chen Duksin, MD Teva Pharmaceutical Industries
Principal Investigator: Giancarlo Comi, Prof Istituto Scientifico Fondazione Centro S. Raffaele
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00337779     History of Changes
Other Study ID Numbers: GA/9016 (FORTE)
Study First Received: June 14, 2006
Results First Received: January 18, 2010
Last Updated: October 6, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014