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:

Information provided by (Responsible Party):

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT01065727

First received: February 8, 2010

Last updated: November 30, 2012

Last verified: November 2012

History of Changes

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 Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

progressive neurological disability [ Time Frame: 3 years ] [ Designated as safety issue: No ]


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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


Responsible Party:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT01065727 History of Changes
Other Study ID Numbers:	PHRC/09-06
Study First Received:	February 8, 2010
Last Updated:	November 30, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:


Reemitting aggressive multiple sclerosis

Additional relevant MeSH terms:


Multiple Sclerosis Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Pathologic Processes Adjuvants, Immunologic Immunologic Factors Mitoxantrone	Analgesics Antineoplastic Agents Central Nervous System Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on March 01, 2015

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