Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01065727

Acronym

IQUALYSEP

Enrollment

144

Registered

2010-02-09

Start date

2010-03-01

Completion date

2023-11-01

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Reemitting aggressive multiple sclerosis

Brief summary

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

Interventions

OTHERmitoxantrone - immunomodulator

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

OTHERnatalizumab

monthly natalizumab during 3 years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
cost effectiveness	30 years

Secondary

Measure	Time frame
progressive neurological disability	3 years

Countries

France

Contacts

PRINCIPAL_INVESTIGATOREdan Gilles, MD PhD

Rennes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026