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OpenTrials
Completed

NCT Number: NCT01065727

Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Cavale Blanche, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mitoxantrone - immunomodulator

Other

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

Natalizumab

Other

monthly natalizumab during 3 years

Primary outcomes

  1. cost effectiveness

    Time frame: 30 years

Secondary outcomes

  1. progressive neurological disability

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: IQUALYSEP

Important dates

Study start
2010
Primary completion
2022
Study completion
2023
First posted
Feb 9, 2010
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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