Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis

Study Overview
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Brief Summary
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The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on EDSS scale in patients with clinically very active relapsing-remitting multiple sclerosis.

Official Title
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Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1b

Conditions
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Relapsing-Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Mitoxantrone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age : 18-45 years, Clinical disease satisfying the Poser criteria (Amdmt n°4) relapsing-remitting disease (Amdmt N°4) at least 2 exacerbations within the preceding 12 months, having left sequelae, MRI activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial MRI with 0.1mmol/kg gadolinium), a significant disability at inclusion: EDSS score between 2.5 and 5.5 (Amdt N° 4) written informed consent Exclusion Criteria: pregnancy and breast-feeding use of an insufficiency effective contraceptive method, general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation treatment with azathioprine during the 3 months preceding the study clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion, associated disease (psychiatric disorder, depressive statenot controlled by appropriate drug therapy, history of heart disease at inclusion examination

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mitoxantrone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to confirmed progression of at least one EDSS point during the 3 years of the study. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - percentage of patients with confirmed progression of at least one point EDSS (confirmed at 3 and 6 months) during the 3 years of the study, |  |  | 
| - annual rate of relapse; |  |  | 
| - percentage of relapse-free patients during the study period, |  |  | 
| - quality of life, |  |  | 
| - percentage of patients without evidence of disease activity on serial MRIs at months 9, 24 and 36 (number of contrast-enhanced lesions on the annual MRIs, change in lesion burden). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, Mitoxantrone, Methylprednisolone, Interferon beta1b, Relapse, MRI, EDSS