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

June 14, 2006
October 6, 2011
August 2006
October 2008   (final data collection date for primary outcome measure)
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.
The total number of confirmed relapses
Complete list of historical versions of study NCT00337779 on ClinicalTrials.gov Archive Site
  • 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.
  • The time to the first confirmed relapse
  • The proportion (%) of subjects who relapsed
  • The number of new T2 lesions at termination as compared to baseline MRI scan
  • The total number of T1-Gd enhancing lesions at months 3, 6, 9 and 12 (Frequent MRI Cohort)
Not Provided
Not Provided
 
Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Relapsing Remitting Multiple Sclerosis
  • Drug: Glatiramer Acetate (GA) 40 mg
    Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months
    Other Name: Copaxone®
  • Drug: glatiramer acetate 20 mg
    Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months
    Other Name: Copaxone®
  • Active Comparator: glatiramer acetate 40 mg
    Intervention: Drug: Glatiramer Acetate (GA) 40 mg
  • Active Comparator: glatiramer acetate 20 mg
    Intervention: Drug: glatiramer acetate 20 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1155
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00337779
GA/9016 (FORTE)
Not Provided
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Study Chair: Chen Duksin, MD Teva Pharmaceutical Industries
Principal Investigator: Giancarlo Comi, Prof Istituto Scientifico Fondazione Centro S. Raffaele
Teva Pharmaceutical Industries
October 2011

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