Multiple Sclerosis
Conditions
Brief summary
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).
Interventions
OTHERNO INTERVENTION
NO INTERVENTION
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
- Patients with RRMS (2017 Mc Donald criteria) treated with highly active treatment in the first 5 years of symptoms onset, at least 1 year, with an EDSS below 4 * HAT start after April 12th 2007 (availability of Natalizumab) * Naive or failure (or intolerability) to 1 or more first line DMT (injectables, teriflunomide, DMF). * EDSS \< or equal 4 when starting HAT
Exclusion criteria
* Progressive relapsing MS at baseline * Clinical or basic MRI data unavailable after on-site visit. * MS diagnostic \> 5 years at baseline * Immunosuppressive drugs (Azathioprine, Cyclophosphamide, Mycophenolate, Methotrexate) prescribed before HAT initiation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of baseline clinical markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment. | Baseline: beginning of highly active treatment | Age in years |
| Determination of baseline MRI markers associated with SPMS diagnosis despite an early, practical, Highly Active Treatment. | Baseline: beginning of highly active treatment | new T2 lesion(s) on brain MRI and spinal cord MRI (if available) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine re-baseline clinical and MRI markers associated with SPMS diagnosis despite an early, practical, HAT. | 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). | At least 1 gadolinium enhancement T1 lesion on MRI |
| Detremination of the impact of different definition of SPMS according to the clinician | 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). | The definition of SPMS according to the clinician : neurological episode = start of progression as assessed by the time to develop SPMS in years. |
| Dertermination of the impact of different definition of SPMS according to Lublin. | at 5 years | 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. |
| To determine re-baseline clinical markers associated with SPMS diagnosis despite an early, practical, HAT. | 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). | Age in years |
| Analyze of the influence of NEDA (No Evidence of Disease activity) | at baseline and at 5 years | The disease activity will be evalued by the NEDA score |
| Analyze of the influence of MEDA (Mild Evidence of Disease Activity) | at baseline and at 5 years | The disease activity will be evalued by the MEDA score |
| To find a composite score usable at baseline when prescribing early HAT in clinical practice to predict early SPMS | at 5 years | All baseline variables will be evaluated in association with the prescriptio of an early HAT to predict early SPMS. |
| Dertermination of the impact of different definition of SPMS according to Lorscheider. | at 5 years | 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. |
| To determine re-baseline MRI markers associated with SPMS diagnosis despite an early, practical, HAT. | 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). | new T2 lesion(s) on brain MRI and spinal cord MRI (if available) |
Countries
France
Outcome results
None listed