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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:
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:

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
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:
Aggression
Multiple Sclerosis
Sclerosis
Behavioral Symptoms
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
 Adjuvants, Immunologic
Immunologic Factors
Mitoxantrone
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013