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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01065727 |
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Date of registration:
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08/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis
IQUALYSEP |
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Scientific title:
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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 |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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250 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01065727 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Edan Gilles, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rennes University Hospital |
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Name:
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Le Page Emmanuelle, MD |
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Address:
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Telephone:
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33-2-9928-5296 |
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Email:
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emmanuelle.lepage@chu-rennes.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Other: mitoxantrone - immunomodulator
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Other: natalizumab
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Primary Outcome(s)
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cost effectiveness
[Time Frame: 30 years]
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Secondary Outcome(s)
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progressive neurological disability
[Time Frame: 3 years]
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Secondary ID(s)
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PHRC/09-06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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