Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
This trial finished 20 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Mitoxantrone
What it measured
Main measures
Time to confirmed progression of at least one EDSS point during the 3 years of the study.
Disability progression
Other measures (5)
- 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,
Disability progression- annual rate of relapse;
Relapses- percentage of relapse-free patients during the study period,
Relapses- quality of life,
Quality of life (reported by participants)- 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).
MRI lesions
Who could take part
Relapsing MS · 18 to 45
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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Related trials
History
Started
Jul 1999
Finished
Jun 2006
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