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

Phase 2

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis
• Interventions: Drug: glatiramer acetate 20 mg; Drug: glatiramer acetate 20 mg, with mitoxantrone

• Registration Number: NCT00203073
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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 available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2005-01
• Study Completion: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Copaxone 20 mg	glatiramer acetate 20 mg	Copaxone 20 mg
Copaxone 20mg with Novantrone induction	glatiramer acetate 20 mg, with mitoxantrone	Copaxone 20mg with Novantrone induction

Primary Outcome Measures

Name	Time	Method
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