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Clinical Trials/NCT01065727
NCT01065727UnknownNot Applicable

Study Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple Sclerosis

Rennes University Hospital4 sites in 1 country250 target enrollmentStarted: February 1, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
250
Locations
4
Primary Endpoint
cost effectiveness
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

cost effectiveness

Time Frame: 30 years

Secondary Outcomes

  • progressive neurological disability(3 years)

Investigators

Sponsor
Rennes University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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