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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00203073
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Teva Pharmaceutical Industries
• Public title: A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.
• Scientific 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.
• Date of first enrolment: June 2003
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00203073
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Siyu Liu, MD
• Affiliation: Teva Neuroscience, Inc.

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: glatiramer acetate 20 mg, with mitoxantrone

Drug: glatiramer acetate 20 mg

Primary Outcome(s)

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]

Secondary ID(s)

NC-100

Source(s) of Monetary Support

Please refer to primary and secondary sponsors