Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).
|ClinicalTrials.gov Identifier: NCT00337779|
Recruitment Status : Completed
First Posted : June 16, 2006
Results First Posted : May 14, 2010
Last Update Posted : October 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Relapsing Remitting Multiple Sclerosis||Drug: Glatiramer Acetate (GA) 40 mg Drug: glatiramer acetate 20 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1155 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
|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®
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337779
|Study Chair:||Chen Duksin, MD||Teva Pharmaceutical Industries, Ltd.|
|Principal Investigator:||Giancarlo Comi, Prof||Istituto Scientifico Fondazione Centro S. Raffaele|