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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001601-10 | EudraCT Number |
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The relative effectiveness of current treatments and their different mechanisms of action yield to consider more and more that the multiple sclerosis (MS) therapeutic approach must use multiple molecules, both combined and sequential.
In this sense, one can assume that the combination of two molecules with different but complementary mechanisms of action, can delay progression of the disease. Mitoxantrone has a powerful action, immediate and total, whereas interferon a selective action, immunomodulatory and delayed.
This study is based on the hypothesis that there is a synergistic effect of both increasing the dose of interferon and also the use of mitoxantrone, allowing to further reduce the conversion rate MS.
Because mitoxantrone decreases the rate of relapses 2 times more than interferon beta, a (at least) 2 times higher benefit on the disease activity is expected with interferon mitoxantrone combination than with interferon alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | Interferon alone |
|
| Experimental group | Experimental | Mitoxantrone for 6 month followed by interferon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta 1a | Drug | Subcutaneous injection of 44µg 3 times a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficacy | Efficacy is judged based on
| Four years after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first relapse | From date of randomization until the date of first documented progression, assessed up to 4 years | |
| Frequency of relapses in 2 years | Within two years following randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles EDAN, MD, PhD | Rennes University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Rennes | Rennes | France |
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| Mitoxantrone | Drug | 10 mg / m² monthly infusion for 6 months |
|
|
| Frequency of relapses in 4 years | Within four years following randomization |
| Changes in the level of disability in 2 years | EDSS score | Two years following randomization |
| Changes in the level of disability in 4 years | EDSS score | Four years following randomization |
| Patients in progression | Rate of patients who progressed to a clinically definite MS (according to the criteria of Mc Donald) in the subgroup of patients who had only one clinical event. | Four years following randomization |
| Disease activity on MRI at 6 months | To compare in the two arms, the rate of patients without radiological (MRI) sign of disease activity | 6 months following randomization |
| Patients without disease activity on MRI at 12 months | To compare in the two arms, the rate of patients without radiological (MRI) sign of disease activity | 12 months following randomization |
| Patients without disease activity on MRI at 24 months | To compare in the two arms, the rate of patients without radiological (MRI) sign of disease activity | 24 months following randomization |
| Patients without disease activity on MRI at 48 months | To compare in the two arms, the rate of patients without radiological (MRI) sign of disease activity | 48 months following randomization |
| Number of visible lesions on MRI at 6 months | To compare in the two arms, the number of lesions taking contrast | 6 months following randomization |
| Number of visible lesions on MRI at 12 months | To compare in the two arms, the number of lesions taking contrast | 12 months following randomization |
| Number of visible lesions on MRI at 24 months | To compare in the two arms, the number of lesions taking contrast | 24 months following randomization |
| Number of visible lesions on MRI at 48 months | To compare in the two arms, the number of lesions taking contrast | 48 months following randomization |
| Lesion load on evaluated T2 weighted MRI at 12 months | 12 months following randomization |
| Lesion load on evaluated T2 weighted MRI at 24 months | 24 months following randomization |
| Lesion load on evaluated T2 weighted MRI at 48 months | 48 months following randomization |
| Brain atrophy | To assess the presence and progression of brain atrophy, changes in the total brain volume after 24 and 48 months will be automatically measured from MR images with dedicated software and expressed as percent change, from a standardized estimation of cerebral volume. | 24 and 48 months following randomization |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| D008942 | Mitoxantrone |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
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