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Completed

NCT Number: NCT00337779

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glatiramer Acetate (GA) 40 mg

Drug

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

Other names: Copaxone®

glatiramer acetate 20 mg

Drug

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

Other names: Copaxone®

Primary outcomes

  1. The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).

    Time frame: 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.

Secondary outcomes

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

    Time frame: 12 months

    The analysis of this endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression including the number of T1 Gd-enhancing lesions at baseline, the volume of T2 lesions at baseline and (pooled) center as covariates.

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

    Time frame: 12 months

    The Frequent MRI Cohort was a subset of subjects consisting of 234 subjects, for whom MRI scans were performed at months 0 (baseline), 1, 2, 3, 6, 9 and 12. Analysis of the endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression with an "offset" variable employing the log of the porportion of the number of available post-baseline scans to adjust for missing MRI scans (if any) and including the number of T1 Gd-enhancing lesions at baseline and (pooled) center as covariates.

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 16, 2006
Registry last updated
Oct 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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