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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
124
Hôpital Cote de Nacre
Caen, France
Hôpital Gabriel Montpied
Clermont-Ferrand, France
Time to confirmed progression of at least one EDSS point during the 3 years of the study.
- 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).
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CHU Henri Mondor
Créteil, France
Hôpital Général
Dijon, France
CHU Limoges
Limoges, France
Institut Catholique de Lille
Lomme, France
Pierre Weitheimer Hospital
Lyon, France
Chu Timone
Marseille, France
Centre Guy de Chauliac
Montpellier, France
CHU Hôpital Central
Nancy, France
...and 13 more locations