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Trial record 5 of 120 for:    COP1

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00203073
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 14, 2011
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date April 14, 2011
Study Start Date  ICMJE June 2003
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
To 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 saf
Change History Complete list of historical versions of study NCT00203073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Relapsing Remitting Multiple Sclerosis
Intervention  ICMJE
  • Drug: glatiramer acetate 20 mg
    glatiramer acetate 20 mg
    Other Name: Copaxone
  • Drug: glatiramer acetate 20 mg, with mitoxantrone
    glatiramer acetate 20 mg, with mitoxantrone
    Other Name: Copaxone, Novantrone
Study Arms  ICMJE
  • Active Comparator: Copaxone 20 mg
    Copaxone 20 mg
    Intervention: Drug: glatiramer acetate 20 mg
  • Active Comparator: Copaxone 20mg with Novantrone induction
    Copaxone 20mg with Novantrone induction
    Intervention: Drug: glatiramer acetate 20 mg, with mitoxantrone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with a relapsing disease course.
  2. 2.EDSS 0.0 - 6.5 inclusive
  3. 18 to 55 years of age
  4. 1 or more T1 Gadolinium-enhancing lesions but no more than 15 lesions
  5. Able and willing to sign and date an informed consent form

Exclusion Criteria:

  1. Patients ever treated with Glatiramer Acetate or Mitoxantrone.
  2. Patients treated with interferons or IV immunoglobulins (IV Ig) in the previous 4 weeks prior to screening visits.
  3. Patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits.
  4. Patients ever treated with cyclophosphamide or Total Lymphoid Irradiation (TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.
  5. Patients treated with intravenous or oral steroids within 28 days prior to initial MRI.
  6. Female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator.
  7. Male patients and their partners must use contraceptive methods deemed reliable by the investigator
  8. LVEF < 50%
  9. Patients using catheters or Foley catheters
  10. 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
  11. Patients with immune deficiency or other medical condition that would preclude treatment with Mitoxantrone or Glatiramer Acetate
  12. 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

  13. Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   United States
 
Administrative Information
NCT Number  ICMJE NCT00203073
Other Study ID Numbers  ICMJE NC-100
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Siyu Liu, VP, NA Innovative R&D, Teva Neuroscience
Study Sponsor  ICMJE Teva Pharmaceutical Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Siyu Liu, MD Teva Neuroscience, Inc.
PRS Account Teva Pharmaceutical Industries
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP