A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.
Relapsing Remitting Multiple Sclerosis
About this trial
This is an interventional diagnostic trial for Relapsing Remitting Multiple Sclerosis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Copaxone 20 mg
Copaxone 20mg with Novantrone induction
Copaxone 20 mg
Copaxone 20mg with Novantrone induction