Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis

Rennes University Hospital144 enrolled

Overview

Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

144

Conditions

Multiple Sclerosis

Interventions

mitoxantrone - immunomodulatorOTHER

mitoxantrone during 6 months and followed by immunomodulator during 2 years and half

natalizumabOTHER

monthly natalizumab during 3 years

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with remitting multiple sclerosis according to mac Donald 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: * patients less than 18 years old

Locations (2)

CHU Cavale Blanche

Brest, France

CHU Rennes

Rennes, France

Outcomes

Primary Outcomes

cost effectiveness

Time frame: 30 years

Secondary Outcomes

progressive neurological disability

Time frame: 3 years

Data from ClinicalTrials.gov

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