Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
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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.
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Accepts Healthy Volunteers:
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
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