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.

Study Overview

• Status: Completed
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Glatiramer Acetate (GA) 40 mg; Drug: glatiramer acetate 20 mg

• Study Type: Interventional
• Enrollment (Actual): 1155
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Copaxone®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Rate of Confirmed Relapses During the Double-blind Phase (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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.	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.	12 months
The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).	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.	12 months

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Chair: Chen Duksin, MD, Teva Pharmaceutical Industries, Ltd.; Principal Investigator: Giancarlo Comi, Prof, Istituto Scientifico Fondazione Centro S. Raffaele

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: June 14, 2006
• First Submitted That Met QC Criteria: June 14, 2006
• First Posted (Estimate): June 16, 2006

Study Record Updates

• Last Update Posted (Estimate): October 10, 2011
• Last Update Submitted That Met QC Criteria: October 6, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Adjuvants, Immunologic; Glatiramer Acetate; (T,G)-A-L
• Other Study ID Numbers: GA/9016 (FORTE)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No