Study of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Aggressive Multiple Sclerosis

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of combinative induction therapy with mitoxantrone and plasmapheresis versus induction therapy with mitoxantrone alone in cases of aggressive multiple sclerosis

Official Title
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Study of Combinative Effect of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Patients With Aggressive Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Procedure: plasmapheresis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aggressive multiple sclerosis in attack phase EDSS: 1-5 No contraindication for mitoxantrone prescription No past history of mitoxantrone injection No history of corticosteroid and immunosuppressive therapy in last 3 months Exclusion Criteria: Patient's incompliance Severe drug induced side effects

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mitoxantrone and plasmapheresis<br>Monthly Plasmapheresis (plasma exchange machine: Haemonetics, model TCS2, USA) 25 ml/kg for 5 cycles, with replacement of 0.9% saline and 5% human serum albumin followed by monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) at the end of each Plasmapheresis course for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals. | Procedure: plasmapheresis<br>* 3 courses of plasmapheresis are performed before mitoxantrone injection in first 3 months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone<br>* Other names: plasma exchange;|
| No Intervention: mitoxantrone<br>Monthly IV infusion of 12 mg/m2 mitoxantrone (EBEWE Pharma, Amsterdam, The Netherlands) for three successive months. Then, treatment is continued by adding two more 6 mg/m2 doses of mitoxantrone in 3-month intervals. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expanded Disability Status Score | The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and defines functional systems as pyramidalm, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral and others. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | At the end of month 8 after treatment initiation | 
| Change From Baseline in Mean Number of MS Plaques Found on Brain MRI | Change From Baseline in Mean Number of MS plaques found on Brain MRI 8 months after treatment initiation | Month 8 after treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, mitoxantrone, plasmapheresis, induction therapy