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

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00203073

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing Remitting Multiple Sclerosis	Drug: glatiramer acetate 20 mg Drug: glatiramer acetate 20 mg, with mitoxantrone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Apr 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Copaxone 20 mg Copaxone 20 mg	Drug: glatiramer acetate 20 mg glatiramer acetate 20 mg Other Names: Copaxone
Active Comparator: Copaxone 20mg with Novantrone induction Copaxone 20mg with Novantrone induction	Drug: glatiramer acetate 20 mg, with mitoxantrone glatiramer acetate 20 mg, with mitoxantrone Other Names: Copaxone, Novantrone

Arm

Intervention/Treatment

Active Comparator: Copaxone 20 mg

Copaxone 20 mg

Drug: glatiramer acetate 20 mg

glatiramer acetate 20 mg

Other Names:

Copaxone

Active Comparator: Copaxone 20mg with Novantrone induction

Copaxone 20mg with Novantrone induction

Drug: glatiramer acetate 20 mg, with mitoxantrone

glatiramer acetate 20 mg, with mitoxantrone

Other Names:

Copaxone, Novantrone

Outcome Measures

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 [15 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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