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

This study is currently recruiting participants.
Verified November 2012 by Rennes University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065727
First Posted: February 9, 2010
Last Update Posted: December 3, 2012
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rennes University Hospital
February 8, 2010
February 9, 2010
December 3, 2012
February 2010
February 2016   (Final data collection date for primary outcome measure)
cost effectiveness [ Time Frame: 30 years ]
Same as current
Complete list of historical versions of study NCT01065727 on ClinicalTrials.gov Archive Site
progressive neurological disability [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
 
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
Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Multiple Sclerosis
  • Other: mitoxantrone - immunomodulator
    mitoxantrone during 6 months and followed by immunomodulator during 2 years and half
  • Other: natalizumab
    monthly natalizumab during 3 years
  • Experimental: mitoxantrone followed by immunomodulator
    Intervention: Other: mitoxantrone - immunomodulator
  • Active Comparator: natalizumab
    Intervention: Other: natalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
February 2019
February 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Le Page Emmanuelle, MD 33-2-9928-5296 emmanuelle.lepage@chu-rennes.fr
France
 
 
NCT01065727
PHRC/09-06
Yes
Not Provided
Not Provided
Rennes University Hospital
Rennes University Hospital
Not Provided
Principal Investigator: Edan Gilles, MD PhD Rennes University Hospital
Rennes University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP