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Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Glatiramer Acetate
Betaseron
Rebif
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry Patients must have experienced at least one documented relapse during the past year prior to screening. Pseudo-relapses must be ruled out. A gadolinium enhancing lesion is not required. Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive Patients must be between the ages of 18 and 50 years inclusive Women of childbearing potential must practice an acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, double-barrier method (condom or IUD with spermicide), or partner's vasectomy Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit Patients must be relapse-free and off corticosteroids between the screening and baseline visits Patients must be willing and able to give written informed consent Exclusion Criteria: Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry Previous treatment with glatiramer acetate (injectable) Previous treatment with immunomodulators (except IFNβ), immunosuppressive agents, IVIG, or plasma exchange in the 6 months prior to screening; previous treatment with cladribine in the past 2 years Previous total body irradiation or total lymphoid irradiation Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry Pregnancy or breastfeeding Life-threatening or other clinically significant disease Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse A known sensitivity to gadolinium (gadolinium acid) A known history of sensitivity to mannitol Inability to successfully undergo MRI scanning

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Glatiramer Acetate 20 mg s.c. daily

    Betaseron 250 ug every other day or Rebif 44 ug 3 times a week

    Outcomes

    Primary Outcome Measures

    The primary objective of the study is to compare the total number of confirmed relapses experienced by patients randomized to maintain treatment on high dose IFN therapy compared to those who were switched to Copaxone® treatment.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    October 14, 2010
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00202995
    Brief Title
    Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS
    Official Title
    A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Terminated
    Why Stopped
    Slow enrollment decreased sample size No unexpected safety issues.
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    October 2007 (Actual)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to Copaxone®

    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
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    91 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Glatiramer Acetate 20 mg s.c. daily
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Betaseron 250 ug every other day or Rebif 44 ug 3 times a week
    Intervention Type
    Drug
    Intervention Name(s)
    Glatiramer Acetate
    Intervention Description
    20 mg s.c. daily
    Intervention Type
    Drug
    Intervention Name(s)
    Betaseron
    Intervention Description
    250 mg every other day
    Intervention Type
    Drug
    Intervention Name(s)
    Rebif
    Intervention Description
    44 ug 3 times a week
    Primary Outcome Measure Information:
    Title
    The primary objective of the study is to compare the total number of confirmed relapses experienced by patients randomized to maintain treatment on high dose IFN therapy compared to those who were switched to Copaxone® treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have a diagnosis of clinically definite MS with a relapsing disease course as determined by the Poser criteria Patients must be on high dose interferon therapy (Betaseron® 250 µg or Rebif® 44 µg) for at least 1 year prior to study entry Patients must have experienced at least one documented relapse during the past year prior to screening. Pseudo-relapses must be ruled out. A gadolinium enhancing lesion is not required. Patients must be ambulatory, with a Kurtzke EDSS score between 0-5 inclusive Patients must be between the ages of 18 and 50 years inclusive Women of childbearing potential must practice an acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, double-barrier method (condom or IUD with spermicide), or partner's vasectomy Patients must be relapse-free and off corticosteroids (IV or oral) for at least 30 days prior to the screening visit Patients must be relapse-free and off corticosteroids between the screening and baseline visits Patients must be willing and able to give written informed consent Exclusion Criteria: Use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry Previous treatment with glatiramer acetate (injectable) Previous treatment with immunomodulators (except IFNβ), immunosuppressive agents, IVIG, or plasma exchange in the 6 months prior to screening; previous treatment with cladribine in the past 2 years Previous total body irradiation or total lymphoid irradiation Chronic corticosteroid (IV, IM, and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry Pregnancy or breastfeeding Life-threatening or other clinically significant disease Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse A known sensitivity to gadolinium (gadolinium acid) A known history of sensitivity to mannitol Inability to successfully undergo MRI scanning
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Helene Brooks
    Organizational Affiliation
    Teva Neuroscience, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS

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