Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis (IQUALYSEP)
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
mitoxantrone - immunomodulator
natalizumab
Sponsored by
About this trial
This is an interventional health services research trial for Multiple Sclerosis focused on measuring Reemitting aggressive multiple sclerosis
Eligibility 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
Sites / Locations
- CHU Cavale BlancheRecruiting
- CHU RennesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mitoxantrone followed by immunomodulator
natalizumab
Arm Description
Outcomes
Primary Outcome Measures
cost effectiveness
Secondary Outcome Measures
progressive neurological disability
Full Information
NCT ID
NCT01065727
First Posted
February 8, 2010
Last Updated
November 30, 2012
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01065727
Brief Title
Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis
Acronym
IQUALYSEP
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 Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Reemitting aggressive multiple sclerosis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mitoxantrone followed by immunomodulator
Arm Type
Experimental
Arm Title
natalizumab
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
mitoxantrone - immunomodulator
Intervention Description
mitoxantrone during 6 months and followed by immunomodulator during 2 years and half
Intervention Type
Other
Intervention Name(s)
natalizumab
Intervention Description
monthly natalizumab during 3 years
Primary Outcome Measure Information:
Title
cost effectiveness
Time Frame
30 years
Secondary Outcome Measure Information:
Title
progressive neurological disability
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Le Page Emmanuelle, MD
Phone
33-2-9928-5296
Email
emmanuelle.lepage@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edan Gilles, MD PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rouhart Francois, MD
Email
francois.rouhart@chu-brest.fr
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmauelle Le Page, MD
Email
emmanuelle.lepage@chu-rennes.fr
12. IPD Sharing Statement
Learn more about this trial
Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis
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