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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01065727
Recruitment Status : Unknown
Verified November 2012 by Rennes University Hospital.
Recruitment status was:  Recruiting
First Posted : February 9, 2010
Last Update Posted : December 3, 2012
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: mitoxantrone - immunomodulator Other: natalizumab Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
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
Study Start Date : February 2010
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. cost effectiveness [ Time Frame: 30 years ]

Secondary Outcome Measures :
  1. progressive neurological disability [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Contact: Le Page Emmanuelle, MD 33-2-9928-5296 emmanuelle.lepage@chu-rennes.fr

Locations
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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
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Principal Investigator: Edan Gilles, MD PhD Rennes University Hospital
More Information
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01065727    
Other Study ID Numbers: PHRC/09-06
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012
Keywords provided by Rennes University Hospital:
Reemitting aggressive multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
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