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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Glatiramer Acetate (GA) 40 mg; Drug: glatiramer acetate 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00337779

GA/9016 (FORTE)

Details and patient eligibility

About

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.

Enrollment: 1,155 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,155 participants in 2 patient groups

glatiramer acetate 40 mg

Active Comparator group

Treatment:

Drug: Glatiramer Acetate (GA) 40 mg

glatiramer acetate 20 mg

Active Comparator group

Treatment:

Drug: glatiramer acetate 20 mg