Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis (IQUALYSEP)

Rennes University Hospital

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Other: natalizumab; Other: mitoxantrone - immunomodulator

Study type: Interventional

Funder types: Other

Identifiers

NCT01065727

PHRC/09-06

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

mitoxantrone followed by immunomodulator

Experimental group

Treatment:

Other: mitoxantrone - immunomodulator

natalizumab

Active Comparator group

Treatment:

Other: natalizumab