National, multicenter study: The study consists of 3 periods: 1. A baseline visit to confirm that patient is still in CIS status. All patients will be clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to exclude MS patients according to 2010 Mc Donald's criteria. 2. Treatment period with timed evaluations 3. Post-treatment period: 4 weeks, with 2 visits following study drug discontinuation and accelerated elimination procedure. All patients who discontinue the study drug and according to investgator's decision, will perform the accelerated elimination procedure and the post- accelerated elimination visits (at 2 and 4 weeks after the end of treatment (EOT).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
CHU de Besançon
Besançon, France
CHU de Lille
Lille, France
CHU de Montpellier
Montpellier, France
CHU de Nice
Nice, France
CHU de Strasbourg
Strasbourg, France
Adverse event reporting
evaluation of safety and tolerability of teriflunomide 14mg per day
Time frame: throughout study completion an average of 6 months
Adverse Events That Are Related to Treatment
Time frame: throughout study completion an average of 6 months
Conversion based on MRI
Conversion to definite MS based on MRI data as defined by the demonstration of dissemination of MRI lesions in time (based on the 2010 revised McDonald criteria) within 3 years
Time frame: throughout study completion an average of 6 months
Conversion based on Clinical evaluation
Conversion to clinically definite MS based on clinical evaluation and annualized relapse rate (ARR), defined as number of relapses per patient-year
Time frame: throughout study completion an average of 6 months
Conversion based on annualized relapse rate (ARR)
Conversion to clinically definite MS based on clinical evaluation and annualized relapse rate (ARR), defined as number of relapses per patient-year
Time frame: throughout study completion an average of 6 months
volume of abnormal brain tissue on MRI
Time frame: 3 years
Disability progression defined as a 1.0-point increase in EDSS score
to disability progression (12 weeks), defined as a 1.0-point increase in EDSS score (or 0.5-point increase for baseline EDSS \>5.5) confirmed after at least 12 weeks
Time frame: confirmed after at least 12 weeks
Proportion of disability-free subjects as assessed by the EDSS
Proportion of disability-free subjects as assessed by the EDSS
Time frame: throughout study completion an average of 1 year
Fatigue Impact Scale
Patient-reported fatigue based on the Fatigue Impact Scale
Time frame: throughout study completion an average of 1 year
Quality of life using SF-36
Time frame: throughout study completion an average of 1 year
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