Real-World Data (RWD) exploring the natural history of MS suggested that relapses do not significantly influence the progression of irreversible disability. Disability progression independent of relapses activity (PIRA) has been confirmed as a frequent relapsing-remitting multiple sclerosis (RRMS) phenomenon based on Randomized Clinical Trials (RCT). Recently, RWD demonstrated that the absence of markers of inflammation (No Evidence of Disease Activity (NEDA) at 2 years did not predict long-term stability. Silent progression has been proposed to describe the insidious disability that accrues many patients who satisfy traditional criteria for relapsing-remitting MS. In this study, the investigators would like to evaluate the occurrence of the SPMS in a population of RRMS patient with an Highly Active Treatment (HAT).
Study Type
OBSERVATIONAL
Enrollment
2,230
NO INTERVENTION
CHU de Nice
Nice, France
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Age in years
Time frame: Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Disease duration (which should be \<5 years) in months
Time frame: Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Expanded Disability Status Scale (EDSS) (which must be \<4)
Time frame: Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
new T2 lesion(s) on brain MRI and spinal cord MRI (if available)
Time frame: Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
gadolinium enhancement on brain MRI and spinal cord MRI (if available)
Time frame: Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Interval time between the first and the second relapse in months
Time frame: Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Reason for HAT: naive, or switch
Time frame: Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
Number of relapses since MS onset
Time frame: Baseline: beginning of highly active treatment
Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
DMT administered since MS onset: number of DMT and type
Time frame: Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
More than 9 T2 lesions on MRI
Time frame: Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
At least 1 periventicular T2 lesion on MRI
Time frame: Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
At least 3 periventicular T2 lesions on MRI
Time frame: Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
At least 1 infratentorial T2 lesion on MRI
Time frame: Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
At least 1 spinal cord T2 lesion on MRI
Time frame: Baseline: beginning of highly active treatment
Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment.
At least 1 gadolinium enhancement T1 lesion on MRI
Time frame: Baseline: beginning of highly active treatment
To determine re-baseline clinical markers associated with SPMS diagnosis despite an early, practical, HAT.
Age in years
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline clinical markers associated with SPMS diagnosis despite an early, practical, HAT.
Disease duration (which should be \<5 years) in months
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline clinical markers associated with SPMS diagnosis despite an early, practical, HAT.
EDSS (which must be \<4) +/- 3 months
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
new T2 lesion(s) on brain MRI and spinal cord MRI (if available)
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
gadolinium enhancement on brain MRI and spinal cord MRI (if available)
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
Interval time between the first and the second relapse in months
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
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To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
Number of relapses since MS onset
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
Number of relapse before baseline
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
Disease Modifying Therapies (DMT) administered since MS onset
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
More than 9 T2 lesions on MRI
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
At least 1 periventicular T2 lesion on MRI
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
At least 3 periventicular T2 lesion on MRI
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
At least 1 infratentorial T2 lesion on MRI
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
At least 1 spinal cord T2 lesion on MRI
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
To determine re-baseline clinical and MRI markers associated with SPMS diagnosis despite an early, practical, HAT.
At least 1 gadolinium enhancement T1 lesion on MRI
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
Detremination of the impact of different definition of SPMS according to the clinician
The definition of SPMS according to the clinician : neurological episode = start of progression as assessed by the time to develop SPMS in years.
Time frame: Re-baseline definition: any patient with at least an EDSS and MRI examination performed 12 months after HAT onset. +/- 6 months (from 6 to 18 months).
Dertermination of the impact of different definition of SPMS according to Lublin.
The definition of SPMS according to Lublin : progressive accumulation of disability after a primary relapsing course which must be confirmed at least 6 months after, as assessed by the time to develop SPMS in years.
Time frame: at 5 years
Dertermination of the impact of different definition of SPMS according to Lorscheider.
The definition of SPMS according to Lorscheider: with a minimum EDSS of 4 , an increase by 1 point if the EDSS was between 4 and 5.5, or an increase by 0.5 points if the EDSS was above 5.5, confirmed after 3 months., as assessed by the time to develop SPMS in years.
Time frame: at 5 years
Analyze of the influence of NEDA (No Evidence of Disease activity)
The disease activity will be evalued by the NEDA score
Time frame: at baseline and at 5 years
Analyze of the influence of MEDA (Mild Evidence of Disease Activity)
The disease activity will be evalued by the MEDA score
Time frame: at baseline and at 5 years
To find a composite score usable at baseline when prescribing early HAT in clinical practice to predict early SPMS
All baseline variables will be evaluated in association with the prescriptio of an early HAT to predict early SPMS.
Time frame: at 5 years