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

NCT00337779 | Completed Phase 3 Results

• 1 other identifier: GA/9016 (FORTE)
• Study Type: interventional
• Target: 1,155
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.

  12 months

• The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).

  12 months

Study Arms (2)

glatiramer acetate 40 mg

ACTIVE COMPARATOR

Drug: Glatiramer Acetate (GA) 40 mg

glatiramer acetate 20 mg

ACTIVE COMPARATOR

Drug: glatiramer acetate 20 mg

Interventions

Glatiramer Acetate (GA) 40 mg DRUG

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

Also known as: Copaxone®

glatiramer acetate 40 mg

glatiramer acetate 20 mg DRUG

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

Also known as: Copaxone®

glatiramer acetate 20 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chen Duksin, MD
• Organization: Teva Pharmaceutical Industries, Ltd.

chen.duksin@teva.co.il

972-9-863-4642

Study Officials

• Chen Duksin, MD

  Teva Pharmaceutical Industries, Ltd.

  STUDY CHAIR

• Giancarlo Comi, Prof

  Istituto Scientifico Fondazione Centro S. Raffaele

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 16, 2006
• Study Start: August 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: October 10, 2011
• Results First Posted: May 14, 2010

Record last verified: 2011-10