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

This study is currently recruiting participants.

See

Contacts and Locations

Verified November 2012 by Rennes University Hospital

Sponsor:

ClinicalTrials.gov Identifier:

NCT01065727

First Posted: February 9, 2010

Last Update Posted: December 3, 2012

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Information provided by (Responsible Party):

Rennes University Hospital

Purpose

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

Condition	Intervention
Multiple Sclerosis	Other: mitoxantrone - immunomodulator Other: natalizumab


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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Mitoxantrone Mitoxantrone hydrochloride Natalizumab

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:

cost effectiveness [ Time Frame: 30 years ]

Secondary Outcome Measures:

progressive neurological disability [ Time Frame: 3 years ]


Estimated Enrollment:	250
Study Start Date:	February 2010
Estimated Study Completion Date:	February 2019
Estimated Primary Completion Date:	February 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: mitoxantrone followed by immunomodulator	Other: mitoxantrone - immunomodulator mitoxantrone during 6 months and followed by immunomodulator during 2 years and half
Active Comparator: natalizumab	Other: natalizumab monthly natalizumab during 3 years

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065727

Contacts


Contact: Le Page Emmanuelle, MD	33-2-9928-5296	emmanuelle.lepage@chu-rennes.fr

Locations


France
CHU Cavale Blanche	Recruiting
Brest, France, 29609
Contact: Rouhart Francois, MD francois.rouhart@chu-brest.fr
CHU Rennes	Recruiting
Rennes, France, 35033
Contact: Emmauelle Le Page, MD emmanuelle.lepage@chu-rennes.fr

Sponsors and Collaborators

Rennes University Hospital

Investigators


Principal Investigator:	Edan Gilles, MD PhD	Rennes University Hospital

More Information


Responsible Party:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT01065727 History of Changes
Other Study ID Numbers:	PHRC/09-06
First Submitted:	February 8, 2010
First Posted:	February 9, 2010
Last Update Posted:	December 3, 2012
Last Verified:	November 2012

Keywords provided by Rennes University Hospital:


Reemitting aggressive multiple sclerosis

Additional relevant MeSH terms:


Sclerosis Multiple Sclerosis Aggression Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Behavioral Symptoms Mitoxantrone	Natalizumab Immunologic Factors Adjuvants, Immunologic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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