search
Back to results

A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
glatiramer acetate 20 mg
glatiramer acetate 20 mg, with mitoxantrone
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

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

Inclusion Criteria: Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with a relapsing disease course. 2.EDSS 0.0 - 6.5 inclusive 18 to 55 years of age 1 or more T1 Gadolinium-enhancing lesions but no more than 15 lesions Able and willing to sign and date an informed consent form Exclusion Criteria: Patients ever treated with Glatiramer Acetate or Mitoxantrone. Patients treated with interferons or IV immunoglobulins (IV Ig) in the previous 4 weeks prior to screening visits. Patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits. Patients ever treated with cyclophosphamide or Total Lymphoid Irradiation (TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy. Patients treated with intravenous or oral steroids within 28 days prior to initial MRI. Female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator. Male patients and their partners must use contraceptive methods deemed reliable by the investigator LVEF < 50% Patients using catheters or Foley catheters Patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: ALS, cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome (i.e., due to heredodegeneration), B12/folate deficiency, lyme disease, HTLV 1-myelopathy Patients with immune deficiency or other medical condition that would preclude treatment with Mitoxantrone or Glatiramer Acetate Abnormal screening blood tests exceeding any of the limits defined below: Alanine transaminase (ALT) - twice the upper limit of normal Aspartate transaminase (AST) - twice the upper limit of normal Total white blood cell count < 2.3 x 103/uL Baseline neutrophil counts of < 1.5 x103/uL Platelet count < 80 x 103/uL Creatinine >1.5 mg/dL Prothrombin time greater than 150% upper limit of normal Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Copaxone 20 mg

    Copaxone 20mg with Novantrone induction

    Arm Description

    Copaxone 20 mg

    Copaxone 20mg with Novantrone induction

    Outcomes

    Primary Outcome Measures

    Determine if short-term immunosuppression with mitoxantrone (Novantrone®) followed by chronic treatment with Glatiramer Acetate (GA) in comparison to treatment with GA for the same period of time but without immunosuppression is well-tolerated and safe

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    April 13, 2011
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00203073
    Brief Title
    A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.
    Official Title
    A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2003 (undefined)
    Primary Completion Date
    January 2005 (Actual)
    Study Completion Date
    April 2005 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    It is thought that treating multiple sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of 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
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Copaxone 20 mg
    Arm Type
    Active Comparator
    Arm Description
    Copaxone 20 mg
    Arm Title
    Copaxone 20mg with Novantrone induction
    Arm Type
    Active Comparator
    Arm Description
    Copaxone 20mg with Novantrone induction
    Intervention Type
    Drug
    Intervention Name(s)
    glatiramer acetate 20 mg
    Other Intervention Name(s)
    Copaxone
    Intervention Description
    glatiramer acetate 20 mg
    Intervention Type
    Drug
    Intervention Name(s)
    glatiramer acetate 20 mg, with mitoxantrone
    Other Intervention Name(s)
    Copaxone, Novantrone
    Intervention Description
    glatiramer acetate 20 mg, with mitoxantrone
    Primary Outcome Measure Information:
    Title
    Determine if short-term immunosuppression with mitoxantrone (Novantrone®) followed by chronic treatment with Glatiramer Acetate (GA) in comparison to treatment with GA for the same period of time but without immunosuppression is well-tolerated and safe
    Time Frame
    15 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: Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with a relapsing disease course. 2.EDSS 0.0 - 6.5 inclusive 18 to 55 years of age 1 or more T1 Gadolinium-enhancing lesions but no more than 15 lesions Able and willing to sign and date an informed consent form Exclusion Criteria: Patients ever treated with Glatiramer Acetate or Mitoxantrone. Patients treated with interferons or IV immunoglobulins (IV Ig) in the previous 4 weeks prior to screening visits. Patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits. Patients ever treated with cyclophosphamide or Total Lymphoid Irradiation (TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy. Patients treated with intravenous or oral steroids within 28 days prior to initial MRI. Female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator. Male patients and their partners must use contraceptive methods deemed reliable by the investigator LVEF < 50% Patients using catheters or Foley catheters Patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: ALS, cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome (i.e., due to heredodegeneration), B12/folate deficiency, lyme disease, HTLV 1-myelopathy Patients with immune deficiency or other medical condition that would preclude treatment with Mitoxantrone or Glatiramer Acetate Abnormal screening blood tests exceeding any of the limits defined below: Alanine transaminase (ALT) - twice the upper limit of normal Aspartate transaminase (AST) - twice the upper limit of normal Total white blood cell count < 2.3 x 103/uL Baseline neutrophil counts of < 1.5 x103/uL Platelet count < 80 x 103/uL Creatinine >1.5 mg/dL Prothrombin time greater than 150% upper limit of normal Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Siyu Liu, MD
    Organizational Affiliation
    Teva Neuroscience, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.

    We'll reach out to this number within 24 hrs