A multi-national, multi-centre, 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 (RR) Multiple Sclerosis (MS) - FORTE

Teva Pharmaceutical Industries, Ltd.0 sites980 target enrollmentAugust 28, 2006

Overview

No summary available.

Registry

who.int

Start Date

August 28, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Subjects must have a confirmed and documented MS diganosis as defined by the Revised McDonald criteria \[Ann Neurol 2005: 58:840\-846].
•2\. Subjects must be of RR MS type \[Neurol 1996;46:907\-911].
•3\. Subjects must be relapse free and in stable neurological condition at least 30 days prior to screening.
•4\. Subjects must have experienced one of the following:
•\+ At least one documented relapse in the 12 months prior to screening.
•\+ At least two documented relapses in the 24 months prior to screening.
•\+ One documented relapse between 12 and 24 months prior to screening with at
•least one documented T1\-Gd enhancing lesion in an MRI performed within 12
•months prior to screening.
•5\. Subjects must have a disease duration of at least 6 months prior to screening.

•1\. Any treatment with corticosteroids (IV, IM and/or PO) within 30 days prior to screening.
•2\. An onset of relapse or any treatment with corticosteroids (IV, IM and/or PO) between month \-1 (screening) and month 0 (baseline).
•3\. Chronic (more than 30 consecutive days) corticosteroid treatment (IV, IM; and/or PO) within 6 months prior to screening visit.
•4\. Use of cladribine within 2 years prior to screening.
•5\. Previous total body or lymphoid irradiation.
•6\. Use of immunosuppressive agents (including mitoxantrone) within 6 months prior to screening visit.
•7\. Previous treatment with immunomodulators (including IFN beta 1a and 1b, and IV immunoglobulin) within 2 months prior to screening.
•8\. Previous use of GA.
•9\. Previous use of natalizumab.
•10\. Previous stem cell treatment.