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

This study is ongoing, but not recruiting participants.

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00337779

Purpose

Teva is developing 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 2 years.

Condition	Intervention	Phase
Relapsing Remitting Multiple Sclerosis	Drug: Glatiramer Acetate (GA)	Phase III

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Copolymer 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

The rate of confirmed relapses during the double-blind phase (12 months).

Secondary Outcome Measures:

The cumulative number of T1-Gd enhancing lesions at months 3, 6, 9 and 12 (Frequent MRI Cohort)
The number of new T2 lesions at month 12 (end of double-blind phase) as compared to baseline scan.

Estimated Enrollment:	980
Study Start Date:	August 2006
Estimated Study Completion Date:	March 2009

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of confirmed and documented MS defined by the Revised McDonald criteria.
Subjects must be of the relapsing-remitting (R-R) type.
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.
Disease duration for at least 6 months.
Ambulatory with converted Kurtzke EDSS score of 0 - 5.
Relapse free and stable neurological condition at least for 30 days prior screening.
Age – 18-55 (inclusive)

Exclusion Criteria:

Previous use of Copaxone (glatiramer acetate)
Treatment with corticosteroids within 30 days prior screening or between screening and baseline.
Chronic corticosteroids treatment - more than 30 consecutive days.
Subject with any clinically significant or unstable medical condition.
Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
Known history of sensitivity to Gadolinium and inability to successfully undergo MRI scanning.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337779

Show 59 Study Locations

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Chair:

Judith Zwickel, PhD

Teva Pharmaceutical Industries LTD

More Information

Study ID Numbers:	GA/9016 (FORTE)
Study First Received:	June 14, 2006
Last Updated:	April 3, 2007
ClinicalTrials.gov Identifier:	NCT00337779
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Copolymer 1
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs

Nervous System Diseases
Adjuvants, Immunologic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009