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

NCT ID: NCT00337779

Last Updated: 2011-10-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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glatiramer acetate 40 mg

Group Type ACTIVE_COMPARATOR

Glatiramer Acetate (GA) 40 mg

Intervention Type DRUG

Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months

glatiramer acetate 20 mg

Group Type ACTIVE_COMPARATOR

glatiramer acetate 20 mg

Intervention Type DRUG

Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months

Interventions

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Glatiramer Acetate (GA) 40 mg

Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months

Intervention Type DRUG

glatiramer acetate 20 mg

Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months

Intervention Type DRUG

Other Intervention Names

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Copaxone® Copaxone®

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chen Duksin, MD

Role: STUDY_CHAIR

Teva Pharmaceutical Industries, Ltd.

Giancarlo Comi, Prof

Role: PRINCIPAL_INVESTIGATOR

Istituto Scientifico Fondazione Centro S. Raffaele

Other Identifiers

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GA/9016 (FORTE)

Identifier Type: -

Identifier Source: org_study_id