Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis
NCT ID: NCT01065727
Last Updated: 2012-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2010-02-28
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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mitoxantrone followed by immunomodulator
mitoxantrone - immunomodulator
mitoxantrone during 6 months and followed by immunomodulator during 2 years and half
natalizumab
natalizumab
monthly natalizumab during 3 years
Interventions
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mitoxantrone - immunomodulator
mitoxantrone during 6 months and followed by immunomodulator during 2 years and half
natalizumab
monthly natalizumab during 3 years
Eligibility Criteria
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Inclusion Criteria
* aggressive remitting multiple sclerosis according to following criteria:
* 2 or less disabling relapse during the 12 months before inclusion
* 1 or more
* EDSS between 2 and 5
* aged less or equal to 40 years old for the women
* effective contraception
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Edan Gilles, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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CHU Cavale Blanche
Brest, , France
CHU Rennes
Rennes, , France
Countries
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Central Contacts
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Facility Contacts
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Rouhart Francois, MD
Role: primary
Emmauelle Le Page, MD
Role: primary
Other Identifiers
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PHRC/09-06
Identifier Type: -
Identifier Source: org_study_id