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

R

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

250 participants in 2 patient groups

mitoxantrone followed by immunomodulator
Experimental group
Treatment:
Other: mitoxantrone - immunomodulator
natalizumab
Active Comparator group
Treatment:
Other: natalizumab

Trial contacts and locations

2

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Central trial contact

Le Page Emmanuelle, MD

Data sourced from clinicaltrials.gov

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