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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Glatiramer Acetate (GA) 40 mg
glatiramer acetate 20 mg
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    glatiramer acetate 40 mg

    glatiramer acetate 20 mg

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.
    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.
    The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).
    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.

    Full Information

    First Posted
    June 14, 2006
    Last Updated
    October 6, 2011
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00337779
    Brief Title
    Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapsing Remitting Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1155 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    glatiramer acetate 40 mg
    Arm Type
    Active Comparator
    Arm Title
    glatiramer acetate 20 mg
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Glatiramer Acetate (GA) 40 mg
    Other Intervention Name(s)
    Copaxone®
    Intervention Description
    Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    glatiramer acetate 20 mg
    Other Intervention Name(s)
    Copaxone®
    Intervention Description
    Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months
    Primary Outcome Measure Information:
    Title
    The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.
    Description
    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.
    Time Frame
    12 months
    Title
    The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chen Duksin, MD
    Organizational Affiliation
    Teva Pharmaceutical Industries, Ltd.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Giancarlo Comi, Prof
    Organizational Affiliation
    Istituto Scientifico Fondazione Centro S. Raffaele
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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